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   <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
   <title>Drug Facts</title>
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      <time/>
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         <representedOrganization>
            <id extension="079944263" root="1.3.6.1.4.1.519.1"/>
            <name>Haleon US Holdings LLC</name>
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               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
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               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <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="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>
                        <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>
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                        </ingredient>
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                           <ingredientSubstance>
                              <code code="WZB9127XOA" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>FD&amp;C RED NO. 40</name>
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                              <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>GLYCERIN</name>
                           </ingredientSubstance>
                        </ingredient>
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                           <ingredientSubstance>
                              <code code="D65DG142WK" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>MALTITOL</name>
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                        </ingredient>
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                              <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>
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                           <quantity>
                              <numerator unit="mL" value="245.5"/>
                              <denominator value="1"/>
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                                 <statusCode code="active"/>
                                 <effectiveTime>
                                    <low value="20150715"/>
                                 </effectiveTime>
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                           <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>
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                              <low value="20150715"/>
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                        </characteristic>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
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               <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="20201215"/>
            </section>
         </component>
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               <id root="a5fff032-055c-4e22-9bd1-0dab5ba931e3"/>
               <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="20201215"/>
            </section>
         </component>
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               <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>
                        <caption>•</caption>temporarily relieves these symptoms due to a cold:<list listType="unordered">
                           <item>
                              <caption>•</caption>minor aches and pains</item>
                           <item>
                              <caption>•</caption>minor sore throat pain</item>
                           <item>
                              <caption>•</caption>headache</item>
                           <item>
                              <caption>•</caption>nasal and sinus congestion</item>
                           <item>
                              <caption>•</caption>cough due to minor throat and bronchial irritation</item>
                        </list>
                     </item>
                     <item>
                        <caption>•</caption>temporarily reduces fever</item>
                  </list>
               </text>
               <effectiveTime value="20201215"/>
            </section>
         </component>
         <component>
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               <id root="32fdc8bc-3d44-4f8b-ad9f-2c1a21b71a85"/>
               <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>
                        <caption>•</caption>more than 4,000 mg of acetaminophen in 24 hours</item>
                     <item>
                        <caption>•</caption>with other drugs containing acetaminophen</item>
                     <item>
                        <caption>•</caption>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>
                        <caption>•</caption>skin reddening</item>
                     <item>
                        <caption>•</caption>blisters</item>
                     <item>
                        <caption>•</caption>rash</item>
                     <item>
                        <caption> </caption>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="20201215"/>
               <component>
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                     <id root="93ab96d6-a7c1-4927-8bbf-78b246ca4e9d"/>
                     <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>
                              <caption>•</caption>in a child under 12 years of age</item>
                           <item>
                              <caption>•</caption>if you are allergic to acetaminophen</item>
                           <item>
                              <caption>•</caption>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>
                              <caption>•</caption>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="20201215"/>
                  </section>
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                     <id root="55cce4d2-02c4-43b2-8c91-c0d33e46f96c"/>
                     <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>
                              <caption>•</caption>liver disease</item>
                           <item>
                              <caption>•</caption>heart disease</item>
                           <item>
                              <caption>•</caption>high blood pressure</item>
                           <item>
                              <caption>•</caption>thyroid disease</item>
                           <item>
                              <caption>•</caption>diabetes</item>
                           <item>
                              <caption>•</caption>trouble urinating due to an enlarged prostate gland</item>
                           <item>
                              <caption>•</caption>cough that occurs with too much phlegm (mucus)</item>
                           <item>
                              <caption>•</caption>cough that lasts or is chronic such as occurs with smoking, asthma or emphysema</item>
                        </list>
                     </text>
                     <effectiveTime value="20201215"/>
                  </section>
               </component>
               <component>
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                     <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>
                              <caption>•</caption>taking the blood thinning drug warfarin</item>
                        </list>
                     </text>
                     <effectiveTime value="20201215"/>
                  </section>
               </component>
               <component>
                  <section ID="ID_1c030247-16e7-4634-9e9f-0f6e526c0d4d">
                     <id root="48e2fce3-8335-4be3-81e7-b2e782826dbf"/>
                     <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>
                              <caption>•</caption>
                              <content styleCode="bold">do not exceed recommended dosage</content>
                           </item>
                        </list>
                     </text>
                     <effectiveTime value="20201215"/>
                  </section>
               </component>
               <component>
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                     <id root="34c19ce1-ccce-4a96-8b63-e555c71b1b3a"/>
                     <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>
                              <caption>•</caption>nervousness, dizziness, or sleeplessness occurs</item>
                           <item>
                              <caption>•</caption>fever gets worse or lasts more than 3 days</item>
                           <item>
                              <caption>•</caption>redness or swelling is present</item>
                           <item>
                              <caption>•</caption>new symptoms occur</item>
                           <item>
                              <caption>•</caption>pain, cough or nasal congestion gets worse or lasts more than 7 days</item>
                           <item>
                              <caption>•</caption>cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.</item>
                        </list>
                     </text>
                     <effectiveTime value="20201215"/>
                  </section>
               </component>
               <component>
                  <section ID="ID_223e34cd-417e-4fda-9045-42dec5631d91">
                     <id root="c69961f1-4c82-4145-af8d-70ac55b5eaeb"/>
                     <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="20201215"/>
                  </section>
               </component>
               <component>
                  <section ID="ID_046a0601-ee6a-4893-bf93-45750a028f93">
                     <id root="6bc1a2dc-9767-41ae-9f80-38f08b4c3f44"/>
                     <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="20201215"/>
                  </section>
               </component>
            </section>
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               <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>
                        <caption>•</caption>
                        <content styleCode="bold">do not use more than directed</content>
                     </item>
                     <item>
                        <caption>•</caption>measure the dose correctly using the enclosed dosing cup</item>
                     <item>
                        <caption>•</caption>take every 4 hours in dosing cup provided, while symptoms persist</item>
                     <item>
                        <caption>•</caption>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>
                                    <caption> </caption>Age</item>
                              </list>
                           </td>
                           <td styleCode="Rrule Botrule Lrule Toprule " valign="top">
                              <list listType="ordered">
                                 <item>
                                    <caption> </caption>Dose</item>
                              </list>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <list listType="ordered">
                                 <item>
                                    <caption> </caption>adults and children 12 years of age and over</item>
                              </list>
                           </td>
                           <td styleCode="Rrule Lrule Botrule " valign="top">
                              <list listType="ordered">
                                 <item>
                                    <caption> </caption>30 mL</item>
                              </list>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Rrule Botrule Lrule " valign="top">
                              <list listType="ordered">
                                 <item>
                                    <caption> </caption>children under 12 years of age</item>
                              </list>
                           </td>
                           <td styleCode="Rrule Botrule Lrule " valign="top">
                              <list listType="ordered">
                                 <item>
                                    <caption> </caption>do not use</item>
                              </list>
                           </td>
                        </tr>
                     </tbody>
                  </table>
               </text>
               <effectiveTime value="20201215"/>
            </section>
         </component>
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               <code code="60561-8" codeSystem="2.16.840.1.113883.6.1" displayName="OTHER SAFETY INFORMATION"/>
               <title>
                  <content styleCode="italics">Other information</content>
               </title>
               <text>
                  <list listType="unordered">
                     <item>
                        <caption>•</caption>
                        <content styleCode="bold">each 30 mL contains</content>: potassium 35 mg, sodium 17 mg</item>
                     <item>
                        <caption>•</caption>store at controlled room temperature 20-25°C (68-77°F)</item>
                  </list>
               </text>
               <effectiveTime value="20201215"/>
            </section>
         </component>
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            <section ID="ID_0e644a92-8e8a-4687-9324-a96bdabacc34">
               <id root="0cdf4d74-325f-4ec0-bf09-0898aaa6e70b"/>
               <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>
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                  <content styleCode="italics">Questions?</content>
               </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">1-800-452-0051</content>
                  </paragraph>
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                     <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 THORAT 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>
                  <paragraph>
                     <content styleCode="bold">* Maximum Strength per 4 hour dose.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING</content>
                  </paragraph>
                  <paragraph>Distributed by: <content styleCode="bold">GSK Consumer Healthcare</content>, Warren, NJ 07059</paragraph>
                  <paragraph>Trademarks are owned by or licensed to the GSK group of companies.</paragraph>
                  <paragraph>©2018 GSK group of companies or its licensor. </paragraph>
                  <paragraph>13271</paragraph>
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