<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="urn:hl7-org:v3" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="15beba82-bd3d-a666-e063-6394a90a8867"/>
   <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
   <title>Drug Facts</title>
   <effectiveTime value="20240410"/>
   <setId root="9736ad4c-8c2e-421f-b023-f91b72d2828b"/>
   <versionNumber value="5"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="079944263"/>
            <name>Haleon US Holdings LLC</name>
            <assignedEntity>
               <assignedOrganization/>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="15bec56e-90cc-e1a4-e063-6394a90a7071"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20240410"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="0067-8125" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Theraflu ExpressMax
<suffix>Daytime Nighttime Value Pack</suffix>
                        </name>
                        <formCode code="C47916" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="KIT"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <asContent>
                           <quantity>
                              <numerator value="1" unit="1"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="0067-8125-16" codeSystem="2.16.840.1.113883.6.69"/>
                              <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                           </containerPackagedProduct>
                           <subjectOf>
                              <characteristic>
                                 <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                                 <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CV"/>
                              </characteristic>
                           </subjectOf>
                           <subjectOf>
                              <marketingAct>
                                 <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 <statusCode code="active"/>
                                 <effectiveTime>
                                    <low value="20150715"/>
                                 </effectiveTime>
                              </marketingAct>
                           </subjectOf>
                        </asContent>
                        <part>
                           <quantity>
                              <numerator value="245.5" unit="mL"/>
                              <denominator value="1"/>
                           </quantity>
                           <partProduct>
                              <code code="0067-8127" codeSystem="2.16.840.1.113883.6.69"/>
                              <name>Theraflu ExpressMax
<suffix>Daytime Severe Cold and Cough</suffix>
                              </name>
                              <formCode code="C42996" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SYRUP"/>
                              <asEntityWithGeneric>
                                 <genericMedicine>
                                    <name>Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl</name>
                                 </genericMedicine>
                              </asEntityWithGeneric>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="23OV73Q5G9" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>ACESULFAME POTASSIUM</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="XF417D3PSL" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>ANHYDROUS CITRIC ACID</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="7FLD91C86K" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>EDETATE DISODIUM</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="H3R47K3TBD" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>FD&amp;C BLUE NO. 1</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="WZB9127XOA" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>FD&amp;C RED NO. 40</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>GLYCERIN</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="D65DG142WK" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>MALTITOL</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="6DC9Q167V3" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>PROPYLENE GLYCOL</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="OJ245FE5EU" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>SODIUM BENZOATE</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="1Q73Q2JULR" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>SODIUM CITRATE, UNSPECIFIED FORM</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>WATER</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="ACTIB">
                                 <quantity>
                                    <numerator unit="mg" value="650"/>
                                    <denominator unit="mL" value="30"/>
                                 </quantity>
                                 <ingredientSubstance>
                                    <code code="362O9ITL9D" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>ACETAMINOPHEN</name>
                                    <activeMoiety>
                                       <activeMoiety>
                                          <code code="362O9ITL9D" codeSystem="2.16.840.1.113883.4.9"/>
                                          <name>ACETAMINOPHEN</name>
                                       </activeMoiety>
                                    </activeMoiety>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="ACTIB">
                                 <quantity>
                                    <numerator unit="mg" value="20"/>
                                    <denominator unit="mL" value="30"/>
                                 </quantity>
                                 <ingredientSubstance>
                                    <code code="9D2RTI9KYH" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>DEXTROMETHORPHAN HYDROBROMIDE</name>
                                    <activeMoiety>
                                       <activeMoiety>
                                          <code code="7355X3ROTS" codeSystem="2.16.840.1.113883.4.9"/>
                                          <name>DEXTROMETHORPHAN</name>
                                       </activeMoiety>
                                    </activeMoiety>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="ACTIB">
                                 <quantity>
                                    <numerator unit="mg" value="10"/>
                                    <denominator unit="mL" value="30"/>
                                 </quantity>
                                 <ingredientSubstance>
                                    <code code="04JA59TNSJ" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>PHENYLEPHRINE HYDROCHLORIDE</name>
                                    <activeMoiety>
                                       <activeMoiety>
                                          <code code="1WS297W6MV" codeSystem="2.16.840.1.113883.4.9"/>
                                          <name>PHENYLEPHRINE</name>
                                       </activeMoiety>
                                    </activeMoiety>
                                 </ingredientSubstance>
                              </ingredient>
                              <asContent>
                                 <quantity>
                                    <numerator value="245.5" unit="mL"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="0067-8127-08" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                                 </containerPackagedProduct>
                                 <subjectOf>
                                    <characteristic>
                                       <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                                       <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CV"/>
                                    </characteristic>
                                 </subjectOf>
                              </asContent>
                           </partProduct>
                           <subjectOf>
                              <approval>
                                 <id extension="M012" root="2.16.840.1.113883.3.9421"/>
                                 <code code="C200263" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OTC Monograph Drug"/>
                                 <author>
                                    <territorialAuthority>
                                       <territory>
                                          <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                       </territory>
                                    </territorialAuthority>
                                 </author>
                              </approval>
                           </subjectOf>
                           <subjectOf>
                              <marketingAct>
                                 <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 <statusCode code="active"/>
                                 <effectiveTime>
                                    <low value="20150715"/>
                                 </effectiveTime>
                              </marketingAct>
                           </subjectOf>
                           <subjectOf>
                              <characteristic classCode="OBS">
                                 <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                                 <value code="C48326" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="red" xsi:type="CE">
                                    <originalText/>
                                 </value>
                              </characteristic>
                           </subjectOf>
                           <subjectOf>
                              <characteristic classCode="OBS">
                                 <code code="SPLFLAVOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                                 <value code="C73365" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BERRY" xsi:type="CE">
                                    <originalText/>
                                 </value>
                              </characteristic>
                           </subjectOf>
                           <consumedIn>
                              <substanceAdministration>
                                 <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                              </substanceAdministration>
                           </consumedIn>
                        </part>
                        <part>
                           <quantity>
                              <numerator value="245.5" unit="mL"/>
                              <denominator value="1"/>
                           </quantity>
                           <partProduct>
                              <code code="0067-8129" codeSystem="2.16.840.1.113883.6.69"/>
                              <name>Theraflu ExpressMax
<suffix>Nighttime Severe Cold and Cough</suffix>
                              </name>
                              <formCode code="C42996" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SYRUP"/>
                              <asEntityWithGeneric>
                                 <genericMedicine>
                                    <name>Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl</name>
                                 </genericMedicine>
                              </asEntityWithGeneric>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="23OV73Q5G9" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>ACESULFAME POTASSIUM</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="XF417D3PSL" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>ANHYDROUS CITRIC ACID</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="7FLD91C86K" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>EDETATE DISODIUM</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="H3R47K3TBD" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>FD&amp;C BLUE NO. 1</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="WZB9127XOA" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>FD&amp;C RED NO. 40</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>GLYCERIN</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="D65DG142WK" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>MALTITOL</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="6DC9Q167V3" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>PROPYLENE GLYCOL</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="OJ245FE5EU" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>SODIUM BENZOATE</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="1Q73Q2JULR" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>SODIUM CITRATE, UNSPECIFIED FORM</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="IACT">
                                 <ingredientSubstance>
                                    <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>WATER</name>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="ACTIB">
                                 <quantity>
                                    <numerator unit="mg" value="650"/>
                                    <denominator unit="mL" value="30"/>
                                 </quantity>
                                 <ingredientSubstance>
                                    <code code="362O9ITL9D" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>ACETAMINOPHEN</name>
                                    <activeMoiety>
                                       <activeMoiety>
                                          <code code="362O9ITL9D" codeSystem="2.16.840.1.113883.4.9"/>
                                          <name>ACETAMINOPHEN</name>
                                       </activeMoiety>
                                    </activeMoiety>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="ACTIB">
                                 <quantity>
                                    <numerator unit="mg" value="25"/>
                                    <denominator unit="mL" value="30"/>
                                 </quantity>
                                 <ingredientSubstance>
                                    <code code="TC2D6JAD40" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>DIPHENHYDRAMINE HYDROCHLORIDE</name>
                                    <activeMoiety>
                                       <activeMoiety>
                                          <code code="8GTS82S83M" codeSystem="2.16.840.1.113883.4.9"/>
                                          <name>DIPHENHYDRAMINE</name>
                                       </activeMoiety>
                                    </activeMoiety>
                                 </ingredientSubstance>
                              </ingredient>
                              <ingredient classCode="ACTIB">
                                 <quantity>
                                    <numerator unit="mg" value="10"/>
                                    <denominator unit="mL" value="30"/>
                                 </quantity>
                                 <ingredientSubstance>
                                    <code code="04JA59TNSJ" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>PHENYLEPHRINE HYDROCHLORIDE</name>
                                    <activeMoiety>
                                       <activeMoiety>
                                          <code code="1WS297W6MV" codeSystem="2.16.840.1.113883.4.9"/>
                                          <name>PHENYLEPHRINE</name>
                                       </activeMoiety>
                                    </activeMoiety>
                                 </ingredientSubstance>
                              </ingredient>
                              <asContent>
                                 <quantity>
                                    <numerator value="245.5" unit="mL"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="0067-8129-08" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                                 </containerPackagedProduct>
                                 <subjectOf>
                                    <characteristic>
                                       <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                                       <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CV"/>
                                    </characteristic>
                                 </subjectOf>
                              </asContent>
                           </partProduct>
                           <subjectOf>
                              <approval>
                                 <id extension="M012" root="2.16.840.1.113883.3.9421"/>
                                 <code code="C200263" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OTC Monograph Drug"/>
                                 <author>
                                    <territorialAuthority>
                                       <territory>
                                          <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                       </territory>
                                    </territorialAuthority>
                                 </author>
                              </approval>
                           </subjectOf>
                           <subjectOf>
                              <marketingAct>
                                 <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                 <statusCode code="active"/>
                                 <effectiveTime>
                                    <low value="20150715"/>
                                 </effectiveTime>
                              </marketingAct>
                           </subjectOf>
                           <subjectOf>
                              <characteristic classCode="OBS">
                                 <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                                 <value code="C48326" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="red" xsi:type="CE">
                                    <originalText/>
                                 </value>
                              </characteristic>
                           </subjectOf>
                           <subjectOf>
                              <characteristic classCode="OBS">
                                 <code code="SPLFLAVOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                                 <value code="C73365" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BERRY" xsi:type="CE">
                                    <originalText/>
                                 </value>
                              </characteristic>
                           </subjectOf>
                           <consumedIn>
                              <substanceAdministration>
                                 <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                              </substanceAdministration>
                           </consumedIn>
                        </part>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="M012" root="2.16.840.1.113883.3.9421"/>
                           <code code="C200263" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OTC Monograph Drug"/>
                           <author>
                              <territorialAuthority>
                                 <territory>
                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                                 </territory>
                              </territorialAuthority>
                           </author>
                        </approval>
                     </subjectOf>
                     <subjectOf>
                        <marketingAct>
                           <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                           <statusCode code="active"/>
                           <effectiveTime>
                              <low value="20150715"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section ID="ID_a3a97b90-b158-426b-9615-3df878d1cd75">
               <id root="15beba82-bd3e-a666-e063-6394a90a8867"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>
                  <content styleCode="italics">Active ingredients (in each 30 mL)</content>
               </title>
               <text>
                  <paragraph>Acetaminophen 650 mg</paragraph>
                  <paragraph>Dextromethorphan HBr 20 mg</paragraph>
                  <paragraph>Phenylephrine HCl 10 mg</paragraph>
               </text>
               <effectiveTime value="20150925"/>
            </section>
         </component>
         <component>
            <section ID="ID_4659791a-575d-4842-98b1-df67d66f24a6">
               <id root="15beba82-bd3f-a666-e063-6394a90a8867"/>
               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <title>
                  <content styleCode="italics">Purposes</content>
               </title>
               <text>
                  <paragraph>Pain reliever/fever reducer</paragraph>
                  <paragraph>Cough suppressant</paragraph>
                  <paragraph>Nasal decongestant</paragraph>
               </text>
               <effectiveTime value="20150925"/>
            </section>
         </component>
         <component>
            <section ID="ID_fc0202a2-c469-4c57-9d9c-9f08278cdf65">
               <id root="15beba82-bd40-a666-e063-6394a90a8867"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>
                  <content styleCode="italics">Uses</content>
               </title>
               <text>
                  <list listType="unordered">
                     <item>temporarily relieves these symptoms due to a cold:
  
   <list listType="unordered">
                           <item>minor aches and pains</item>
                           <item>minor sore throat pain</item>
                           <item>headache</item>
                           <item>nasal and sinus congestion</item>
                           <item>cough due to minor throat and bronchial irritation</item>
                        </list>
                     </item>
                     <item>temporarily reduces fever</item>
                  </list>
               </text>
               <effectiveTime value="20150925"/>
            </section>
         </component>
         <component>
            <section ID="ID_40cc4ed2-1cce-4eed-b098-a8aaaacf6dbc">
               <id root="15beba82-bd41-a666-e063-6394a90a8867"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>
                  <content styleCode="italics">Warnings</content>
               </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Liver warning:</content>This product contains acetaminophen. Severe liver damage may occur if you take

 </paragraph>
                  <list listType="unordered">
                     <item>more than 4,000 mg of acetaminophen in 24 hours</item>
                     <item>with other drugs containing acetaminophen</item>
                     <item>3 or more alcoholic drinks every day while using this product</item>
                  </list>
                  <paragraph>
                     <content styleCode="bold">Allergy alert:</content>Acetaminophen may cause severe skin reactions. Symptoms may include:

 </paragraph>
                  <list listType="unordered">
                     <item>skin reddening</item>
                     <item>blisters</item>
                     <item>rash</item>
                     <item>If a skin reaction occurs, stop use and seek medical help right away.</item>
                  </list>
                  <paragraph>
                     <content styleCode="bold">Sore throat warning:</content>If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

 </paragraph>
               </text>
               <effectiveTime value="20220428"/>
               <component>
                  <section ID="ID_62620f38-fbd3-4bfb-8985-14e3bf879f13">
                     <id root="15beba82-bd42-a666-e063-6394a90a8867"/>
                     <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
                     <title>Do Not Use</title>
                     <text>
                        <list listType="unordered">
                           <item>in a child under 12 years of age</item>
                           <item>if you are allergic to acetaminophen</item>
                           <item>with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.</item>
                           <item>if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.</item>
                        </list>
                     </text>
                     <effectiveTime value="20150901"/>
                  </section>
               </component>
               <component>
                  <section ID="ID_fc26fe64-abba-4f52-a40b-6e60c2c7f82c">
                     <id root="15beba82-bd43-a666-e063-6394a90a8867"/>
                     <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
                     <title>Ask a doctor before use if you have</title>
                     <text>
                        <list listType="unordered">
                           <item>liver disease</item>
                           <item>heart disease</item>
                           <item>high blood pressure</item>
                           <item>thyroid disease</item>
                           <item>diabetes</item>
                           <item>trouble urinating due to an enlarged prostate gland</item>
                           <item>cough that occurs with too much phlegm (mucus)</item>
                           <item>cough that lasts or is chronic such as occurs with smoking, asthma or emphysema</item>
                        </list>
                     </text>
                     <effectiveTime value="20150901"/>
                  </section>
               </component>
               <component>
                  <section ID="ID_3744e114-704b-45bd-8a23-7ef060e0d5ed">
                     <id root="15beba82-bd44-a666-e063-6394a90a8867"/>
                     <code code="50568-5" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR/PHARMACIST SECTION"/>
                     <title>Ask a doctor or pharmacist before use if you are</title>
                     <text>
                        <list listType="unordered">
                           <item>taking the blood thinning drug warfarin</item>
                        </list>
                     </text>
                     <effectiveTime value="20150901"/>
                  </section>
               </component>
               <component>
                  <section ID="ID_14b645c5-128f-4933-9fbd-db034da6f094">
                     <id root="15beba82-bd45-a666-e063-6394a90a8867"/>
                     <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
                     <title>When using this product</title>
                     <text>
                        <list listType="unordered">
                           <item>
                              <content styleCode="bold">do not exceed recommended dosage</content>
                           </item>
                        </list>
                     </text>
                     <effectiveTime value="20150901"/>
                  </section>
               </component>
               <component>
                  <section ID="ID_47224984-eb0e-4438-ae67-e1d127443c84">
                     <id root="15beba82-bd46-a666-e063-6394a90a8867"/>
                     <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
                     <title>Stop use and ask a doctor if</title>
                     <text>
                        <list listType="unordered">
                           <item>nervousness, dizziness, or sleeplessness occurs</item>
                           <item>fever gets worse or lasts more than 3 days</item>
                           <item>redness or swelling is present</item>
                           <item>new symptoms occur</item>
                           <item>pain, cough or nasal congestion gets worse or lasts more than 7 days</item>
                           <item>cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.</item>
                        </list>
                     </text>
                     <effectiveTime value="20220428"/>
                  </section>
               </component>
               <component>
                  <section ID="ID_5316333e-0fcb-467f-be50-5bb54a3a19b3">
                     <id root="15beba82-bd47-a666-e063-6394a90a8867"/>
                     <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
                     <title>If pregnant or breast-feeding,</title>
                     <text>
                        <paragraph>ask a health professional before use.</paragraph>
                     </text>
                     <effectiveTime value="20150901"/>
                  </section>
               </component>
               <component>
                  <section ID="ID_64469f19-cd29-4bdf-b6cc-2563c6bc007c">
                     <id root="15beba82-bd48-a666-e063-6394a90a8867"/>
                     <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
                     <title>Keep out of reach of children.</title>
                     <text>
                        <paragraph>In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.</paragraph>
                     </text>
                     <effectiveTime value="20150901"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section ID="ID_ffd7b40e-174b-42bd-b035-10f69c35c8fe">
               <id root="15beba82-bd49-a666-e063-6394a90a8867"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>
                  <content styleCode="italics">Directions</content>
               </title>
               <text>
                  <list listType="unordered">
                     <item>
                        <content styleCode="bold">do not use more than directed</content>
                     </item>
                     <item>measure the dose correctly using the enclosed dosing cup</item>
                     <item>take every 4 hours in dosing cup provided, while symptoms persist</item>
                     <item>do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor</item>
                  </list>
                  <table width="100%">
                     <col width="72%"/>
                     <col width="28%"/>
                     <tbody>
                        <tr>
                           <td styleCode="Rrule Botrule Lrule Toprule " valign="top">
                              <list listType="ordered">
                                 <item>Age</item>
                              </list>
                           </td>
                           <td styleCode="Rrule Botrule Lrule Toprule " valign="top">
                              <list listType="ordered">
                                 <item>Dose</item>
                              </list>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <list listType="ordered">
                                 <item>adults and children 12 years of age and over</item>
                              </list>
                           </td>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <list listType="ordered">
                                 <item>30 mL</item>
                              </list>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Rrule Botrule Lrule " valign="top">
                              <list listType="ordered">
                                 <item>children under 12 years of age</item>
                              </list>
                           </td>
                           <td styleCode="Rrule Botrule Lrule " valign="top">
                              <list listType="ordered">
                                 <item>do not use</item>
                              </list>
                           </td>
                        </tr>
                     </tbody>
                  </table>
               </text>
               <effectiveTime value="20220428"/>
            </section>
         </component>
         <component>
            <section ID="ID_6d825aef-41a5-4ddd-a857-d1ece2011fc2">
               <id root="15beba82-bd4a-a666-e063-6394a90a8867"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>
                  <content styleCode="italics">Other information</content>
               </title>
               <text>
                  <list listType="unordered">
                     <item>
                        <content styleCode="bold">each 30 mL contains</content>: potassium 35 mg, sodium 17 mg
 
  </item>
                     <item>store at controlled room temperature 20-25°C (68-77°F)</item>
                  </list>
               </text>
               <effectiveTime value="20220428"/>
            </section>
         </component>
         <component>
            <section ID="ID_59a45074-4965-4b5b-b851-b77c1edad6d6">
               <id root="15beba82-bd4b-a666-e063-6394a90a8867"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>
                  <content styleCode="italics">Inactive ingredients</content>
               </title>
               <text>
                  <paragraph>acesulfame potassium, anhydrous citric acid, edetate disodium, FD&amp;C blue no. 1, FD&amp;C red no. 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate</paragraph>
               </text>
               <effectiveTime value="20220428"/>
            </section>
         </component>
         <component>
            <section ID="ID_216b541f-b929-496c-a05e-a833e095daf8">
               <id root="15beba82-bd4c-a666-e063-6394a90a8867"/>
               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <title>
                  <content styleCode="italics">Questions?</content>
               </title>
               <text>
                  <paragraph>call
 
  <content styleCode="bold">1-800-328-5259</content>
                  </paragraph>
               </text>
               <effectiveTime value="20220428"/>
            </section>
         </component>
         <component>
            <section ID="ID_23013632-1e68-4b49-9d5b-47e6471183fb">
               <id root="15beba82-bd4d-a666-e063-6394a90a8867"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Theraflu ExpressMax Nighttime Severe Cold &amp; Cough</title>
               <effectiveTime value="20220428"/>
            </section>
         </component>
         <component>
            <section ID="ID_bb2a6108-68c4-4396-be15-f64050d6feda">
               <id root="15beba82-bd4e-a666-e063-6394a90a8867"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Drug Facts</title>
               <effectiveTime value="20150901"/>
            </section>
         </component>
         <component>
            <section ID="ID_cce7eb5a-b421-428e-9c89-13bedfa46c7a">
               <id root="15beba82-bd4f-a666-e063-6394a90a8867"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>
                  <content styleCode="italics">Active ingredients (in each 30 mL)</content>
               </title>
               <text>
                  <paragraph>Acetaminophen 650 mg</paragraph>
                  <paragraph>Diphenhydramine HCl 25 mg</paragraph>
                  <paragraph>Phenylephrine HCl 10 mg</paragraph>
               </text>
               <effectiveTime value="20220428"/>
            </section>
         </component>
         <component>
            <section ID="ID_16cc8171-633e-44d9-bcaa-7f950cfe79b8">
               <id root="15beba82-bd50-a666-e063-6394a90a8867"/>
               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <title>
                  <content styleCode="italics">Purposes</content>
               </title>
               <text>
                  <paragraph>Pain Reliever/fever reducer</paragraph>
                  <paragraph>Antihistamine/cough suppressant</paragraph>
                  <paragraph>Nasal decongestant</paragraph>
               </text>
               <effectiveTime value="20220428"/>
            </section>
         </component>
         <component>
            <section ID="ID_0f2838e2-5c4c-4088-b192-4395e75438af">
               <id root="15beba82-bd51-a666-e063-6394a90a8867"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>
                  <content styleCode="italics">Uses</content>
               </title>
               <text>
                  <list listType="unordered">
                     <item>temporarily relieves these symptoms due to a cold:
  
   <list listType="unordered">
                           <item>minor aches and pains</item>
                           <item>minor sore throat pain</item>
                           <item>headache</item>
                           <item>nasal and sinus congestion</item>
                           <item>runny nose</item>
                           <item>sneezing</item>
                           <item>itchy nose or throat</item>
                           <item>itchy, watery eyes due to hay fever</item>
                           <item>cough due to minor throat and bronchial irritation</item>
                        </list>
                     </item>
                     <item>temporarily reduces fever</item>
                  </list>
               </text>
               <effectiveTime value="20150925"/>
            </section>
         </component>
         <component>
            <section ID="ID_26105ece-edf1-41d5-a4e5-98a0a446c4db">
               <id root="15beba82-bd52-a666-e063-6394a90a8867"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>
                  <content styleCode="italics">Warnings</content>
               </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Liver warning:</content>This product contains acetaminophen. Severe liver damage may occur if you take

 </paragraph>
                  <list listType="unordered">
                     <item>more than 4,000 mg of acetaminophen in 24 hours</item>
                     <item>with other drugs containing acetaminophen</item>
                     <item>3 or more alcoholic drinks every day while using this product</item>
                  </list>
                  <paragraph>
                     <content styleCode="bold">Allergy alert:</content>Acetaminophen may cause severe skin reactions. Symptoms may include:

 </paragraph>
                  <list listType="unordered">
                     <item>skin reddening</item>
                     <item>blisters</item>
                     <item>rash</item>
                  </list>
                  <paragraph>If a skin reaction occurs, stop use and seek medical help right away.</paragraph>
                  <paragraph>
                     <content styleCode="bold">Sore throat warning:</content>If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

 </paragraph>
               </text>
               <effectiveTime value="20220428"/>
               <component>
                  <section ID="ID_91390fb7-583a-4182-815b-ff55df72fe1b">
                     <id root="15beba82-bd53-a666-e063-6394a90a8867"/>
                     <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
                     <title>Do not use</title>
                     <text>
                        <list listType="unordered">
                           <item>in a child under 12 years of age</item>
                           <item>if you are allergic to acetaminophen</item>
                           <item>with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.</item>
                           <item>with any other product containing diphenhydramine, even one used on the skin</item>
                           <item>if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAO, ask a doctor or pharmacist before taking this product.</item>
                        </list>
                     </text>
                     <effectiveTime value="20220428"/>
                  </section>
               </component>
               <component>
                  <section ID="ID_d6ee68c7-1205-4cb1-980d-b3a7ef7ef128">
                     <id root="15beba82-bd54-a666-e063-6394a90a8867"/>
                     <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
                     <title>Ask a doctor before use if you have</title>
                     <text>
                        <list listType="unordered">
                           <item>liver disease</item>
                           <item>heart disease</item>
                           <item>high blood pressure</item>
                           <item>thyroid disease</item>
                           <item>diabetes</item>
                           <item>glaucoma</item>
                           <item>trouble urinating due to an enlarged prostate gland</item>
                           <item>a breathing problem such as emphysema or chronic bronchitis</item>
                           <item>cough that occurs with too much phlegm (mucus)</item>
                           <item>cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema</item>
                        </list>
                     </text>
                     <effectiveTime value="20150901"/>
                  </section>
               </component>
               <component>
                  <section ID="ID_3a18f08e-540b-4627-8abd-4970818d9fa1">
                     <id root="15beba82-bd55-a666-e063-6394a90a8867"/>
                     <code code="50568-5" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR/PHARMACIST SECTION"/>
                     <title>Ask a doctor or pharmacist before use if you are</title>
                     <text>
                        <list listType="unordered">
                           <item>taking sedatives or tranquilizers</item>
                           <item>taking the blood thinning drug warfarin</item>
                        </list>
                     </text>
                     <effectiveTime value="20150901"/>
                  </section>
               </component>
               <component>
                  <section ID="ID_00014bfc-5a75-4854-8292-159c90f37214">
                     <id root="15beba82-bd56-a666-e063-6394a90a8867"/>
                     <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
                     <title>When using this product</title>
                     <text>
                        <list listType="unordered">
                           <item>
                              <content styleCode="bold">do not exceed recommended dosage</content>
                           </item>
                           <item>avoid alcoholic drinks</item>
                           <item>marked drowsiness may occur</item>
                           <item>alcohol, sedatives, and tranquilizers may increase drowsiness</item>
                           <item>be careful when driving a motor vehicle or operating machinery</item>
                           <item>excitability may occur, especially in children</item>
                        </list>
                     </text>
                     <effectiveTime value="20150901"/>
                  </section>
               </component>
               <component>
                  <section ID="ID_997c4595-0afb-43b2-9121-7983726678ca">
                     <id root="15beba82-bd57-a666-e063-6394a90a8867"/>
                     <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
                     <title>Stop use and ask a doctor if</title>
                     <text>
                        <list listType="unordered">
                           <item>nervousness, dizziness, or sleeplessness occurs</item>
                           <item>fever gets worse or lasts more than 3 days</item>
                           <item>redness or swelling is present</item>
                           <item>new symptoms occur</item>
                           <item>pain, cough or nasal congestion gets worse or lasts more than 7 days</item>
                           <item>cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.</item>
                        </list>
                     </text>
                     <effectiveTime value="20150901"/>
                  </section>
               </component>
               <component>
                  <section ID="ID_eb03ad85-cf61-4ad6-b355-0617ea91f67b">
                     <id root="15beba82-bd58-a666-e063-6394a90a8867"/>
                     <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
                     <title>If pregnant or breast-feeding,</title>
                     <text>
                        <paragraph>ask a health professional before use.</paragraph>
                     </text>
                     <effectiveTime value="20150901"/>
                  </section>
               </component>
               <component>
                  <section ID="ID_76d6d8bb-d19f-4e25-9270-a8385a41ad40">
                     <id root="15beba82-bd59-a666-e063-6394a90a8867"/>
                     <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
                     <title>Keep out of reach of children.</title>
                     <text>
                        <paragraph>In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.</paragraph>
                     </text>
                     <effectiveTime value="20150901"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section ID="ID_434b3d3b-d0d0-4aeb-aeaf-8886981244a9">
               <id root="15beba82-bd5a-a666-e063-6394a90a8867"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>
                  <content styleCode="italics">Directions</content>
               </title>
               <text>
                  <list listType="unordered">
                     <item>
                        <content styleCode="bold">do not use more than directed</content>
                     </item>
                     <item>measure the dose correctly using the enclosed dosing cup</item>
                     <item>take every 4 hours in dosing cup provided, while symptoms persist.</item>
                     <item>do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor</item>
                  </list>
                  <table width="100%">
                     <col width="72%"/>
                     <col width="28%"/>
                     <tbody>
                        <tr>
                           <td styleCode="Rrule Botrule Lrule Toprule " valign="top">
                              <list listType="ordered">
                                 <item>Age</item>
                              </list>
                           </td>
                           <td styleCode="Rrule Botrule Lrule Toprule " valign="top">
                              <list listType="ordered">
                                 <item>Dose</item>
                              </list>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <list listType="ordered">
                                 <item>adults and children 12 years of age and over</item>
                              </list>
                           </td>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <list listType="ordered">
                                 <item>30 mL</item>
                              </list>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Rrule Botrule Lrule " valign="top">
                              <list listType="ordered">
                                 <item>children under 12 years of age</item>
                              </list>
                           </td>
                           <td styleCode="Rrule Botrule Lrule " valign="top">
                              <list listType="ordered">
                                 <item>Do not use</item>
                              </list>
                           </td>
                        </tr>
                     </tbody>
                  </table>
               </text>
               <effectiveTime value="20220428"/>
            </section>
         </component>
         <component>
            <section ID="ID_52ea176c-b313-4095-8a9a-cb425686b6e8">
               <id root="15beba82-bd5b-a666-e063-6394a90a8867"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>
                  <content styleCode="italics">Other information</content>
               </title>
               <text>
                  <list listType="unordered">
                     <item>
                        <content styleCode="bold">each 30 mL contains</content>: potassium 35 mg, sodium 17 mg
 
  </item>
                     <item>store at controlled room temperature 20-25°C (68-77°F)</item>
                  </list>
               </text>
               <effectiveTime value="20220428"/>
            </section>
         </component>
         <component>
            <section ID="ID_5fb83b9d-b29e-4468-b58d-c90d8504c2ec">
               <id root="15beba82-bd5c-a666-e063-6394a90a8867"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>
                  <content styleCode="italics">Inactive ingredients</content>
               </title>
               <text>
                  <paragraph>acesulfame potassium, anhydrous citric acid, edetate disodium, FD&amp;C blue no. 1, FD&amp;C red no. 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate</paragraph>
               </text>
               <effectiveTime value="20220428"/>
            </section>
         </component>
         <component>
            <section ID="ID_41cd8e5e-099c-4deb-9717-6490b36a9989">
               <id root="15beba82-bd5d-a666-e063-6394a90a8867"/>
               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <title>
                  <content styleCode="italics">Questions?</content>
               </title>
               <text>
                  <paragraph>call
 
  <content styleCode="bold">1-800-328-5259</content>
                  </paragraph>
               </text>
               <effectiveTime value="20220428"/>
            </section>
         </component>
         <component>
            <section ID="ID_a67bc2d0-25dc-4c5b-9d53-fa8454590da8">
               <id root="15beba82-bd5e-a666-e063-6394a90a8867"/>
               <code code="60561-8" codeSystem="2.16.840.1.113883.6.1" displayName="OTHER SAFETY INFORMATION"/>
               <title>Other Safety Information</title>
               <text>
                  <paragraph>DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.</paragraph>
                  <paragraph>DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.</paragraph>
                  <paragraph>
                     <content styleCode="bold">PARENTS:</content>Learn about teen medicine abuse

 </paragraph>
                  <paragraph>
                     <linkHtml href="http://www.StopMedicineAbuse.org">www.StopMedicineAbuse.org</linkHtml>
                  </paragraph>
                  <paragraph>TAMPER-EVIDENT INNER UNIT. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING</paragraph>
                  <paragraph>Distributed by:
 
  <content styleCode="bold">GSK Consumer Healthcare</content>
                  </paragraph>
                  <paragraph>Warren, NJ 07059</paragraph>
                  <paragraph>©2019 GSK group of companies or its licensor.</paragraph>
                  <paragraph>13440</paragraph>
               </text>
               <effectiveTime value="20220428"/>
            </section>
         </component>
         <component>
            <section ID="ID_70c05f8c-f404-4d77-a59e-381992489640">
               <id root="15beba82-bd5f-a666-e063-6394a90a8867"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Principal Display Panel</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">NDC 0067-8125-16</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">THERAFLU</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">ExpressMax</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">DAYTIME</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">SEVERE COLD &amp; COUGH</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">BERRY FLAVOR</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">ACETAMINOPHEN</content>
                  </paragraph>
                  <paragraph>PAIN RELIEVER/FEVER REDUCER</paragraph>
                  <paragraph>
                     <content styleCode="bold">DEXTROMETHORPHAN HBr</content>
                  </paragraph>
                  <paragraph>COUGH SUPPRESSANT</paragraph>
                  <paragraph>
                     <content styleCode="bold">PHENYLEPHRINE HCl</content>
                  </paragraph>
                  <paragraph>NASAL DECONGESTANT</paragraph>
                  <paragraph>• Cough • Nasal Congestion</paragraph>
                  <paragraph>• Sore Throat Pain • Fever</paragraph>
                  <paragraph>• Headache • Body Ache</paragraph>
                  <paragraph>8.3 FL OZ (245.5mL)</paragraph>
                  <paragraph>Alcohol Free</paragraph>
                  <paragraph>
                     <content styleCode="bold">DAYTIME</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">THERAFLU</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">ExpressMax</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">NIGHTTIME</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">SEVERE COLD &amp; COUGH</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">BERRY FLAVOR</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">ACETAMINOPHEN</content>
                  </paragraph>
                  <paragraph>PAIN RELIEVER/FEVER REDUCER</paragraph>
                  <paragraph>
                     <content styleCode="bold">DIPHENHYDRAMINE HCl</content>
                  </paragraph>
                  <paragraph>ANTIHISTAMINE/COUGH SUPPRESSANT</paragraph>
                  <paragraph>
                     <content styleCode="bold">PHENYLEPHRINE HCl</content>
                  </paragraph>
                  <paragraph>NASAL DECONGESTANT</paragraph>
                  <paragraph>• Cough • Nasal Congestion</paragraph>
                  <paragraph>• Sore Throat Pain • Fever</paragraph>
                  <paragraph>• Headache • Body Ache</paragraph>
                  <paragraph>• Runny Nose</paragraph>
                  <paragraph>8.3 FL OZ (245.5mL)</paragraph>
                  <paragraph>Alcohol Free</paragraph>
                  <paragraph>
                     <content styleCode="bold">NIGHTTIME</content>
                  </paragraph>
                  <list listType="unordered">
                     <item>
                        <content styleCode="bold">2 – 8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL)</content>Use Only As Directed
 
  </item>
                  </list>
                  <renderMultiMedia ID="id307300068" referencedObject="A4F043F3-060B-44F8-9CDE-744AD32E5178"/>
               </text>
               <effectiveTime value="20220428"/>
               <component>
                  <observationMedia ID="A4F043F3-060B-44F8-9CDE-744AD32E5178">
                     <text>13440_Theraflu DT-NT Severe Cold &amp; Cough Combo pack_2 bottles of 8.3 OZ.JPG</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="image-01.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="ID_c26503d0-74d0-44ff-ad6c-e7a1da378d5d">
               <id root="15beba82-bd60-a666-e063-6394a90a8867"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Principal Display Panel</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">NDC 0067-8127-08</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">THERAFLU</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">ExpressMax</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">DAYTIME</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">SEVERE COLD &amp; COUGH</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">BERRY FLAVOR</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">ACETAMINOPHEN</content>
                  </paragraph>
                  <paragraph>PAIN RELIEVER/FEVER REDUCER</paragraph>
                  <paragraph>
                     <content styleCode="bold">DEXTROMETHORPHAN HBr</content>
                  </paragraph>
                  <paragraph>COUGH SUPPRESSANT</paragraph>
                  <paragraph>
                     <content styleCode="bold">PHENYLEPHRINE HCl</content>
                  </paragraph>
                  <paragraph>NASAL DECONGESTANT</paragraph>
                  <paragraph>
                     <content styleCode="bold">• Cough • Nasal Congestion</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">• Sore Throat Pain • Fever</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">• Headache • Body Ache</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">8.3 FL OZ (245.5mL)</content>
                  </paragraph>
                  <paragraph>Alcohol Free</paragraph>
                  <renderMultiMedia ID="id1508181510" referencedObject="BC052FBD-C71E-485B-88B3-FC5BC08C0B10"/>
               </text>
               <effectiveTime value="20220428"/>
               <component>
                  <observationMedia ID="BC052FBD-C71E-485B-88B3-FC5BC08C0B10">
                     <text>Theraflu ExpressMAX DT SCC.jpg</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="image-02.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
         <component>
            <section ID="ID_647d18ab-74f3-47cb-be0d-223230c8d39c">
               <id root="15beba82-bd61-a666-e063-6394a90a8867"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Principal Display Panel</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">NDC 0067-8129-08</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">THERAFLU</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">ExpressMax</content>
                     </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">NIGHTTIME</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">SEVERE COLD &amp; COUGH</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">BERRY FLAVOR</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">ACETAMINOPHEN</content>
                  </paragraph>
                  <paragraph>PAIN RELIEVER/FEVER REDUCER</paragraph>
                  <paragraph>
                     <content styleCode="bold">DIPHENHYDRAMINE HCl</content>
                  </paragraph>
                  <paragraph>ANTIHISTAMINE/COUGH SUPPRESSANT</paragraph>
                  <paragraph>
                     <content styleCode="bold">PHENYLEPHRINE HCl</content>
                  </paragraph>
                  <paragraph>NASAL DECONGESTANT</paragraph>
                  <paragraph>•
 
  <content styleCode="bold">Cough • Nasal Congestion</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">• Sore Throat Pain • Fever</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">• Headache • Body Ache</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">• Runny Nose</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">8.3 FL OZ (245.5mL)</content>
                  </paragraph>
                  <paragraph>Alcohol Free</paragraph>
                  <renderMultiMedia ID="id-676888253" referencedObject="B403A6A1-B77A-4572-BE9F-EF4186E61E5E"/>
               </text>
               <effectiveTime value="20220428"/>
               <component>
                  <observationMedia ID="B403A6A1-B77A-4572-BE9F-EF4186E61E5E">
                     <text>13414_Theraflu ExpressMAX NT SCC_8.3 OZ.JPG.jpg</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="image-03.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>