<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="http://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 http://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="d77bec74-2c20-4af8-ab25-de94be40f298"/>
   <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
   <title>ASSURED™ MAXIMUM STRENGTH MUCUS RELIEF</title>
   <effectiveTime value="20160804"/>
   <setId root="0d811f94-16b1-4ba8-aeea-6f947b69ba24"/>
   <versionNumber value="1"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="179621011" root="1.3.6.1.4.1.519.1"/>
            <name>SPIRIT PHARMACEUTICALS LLC</name>
            <assignedEntity>
               <assignedOrganization>
                  <assignedEntity>
                     <assignedOrganization>
                        <id extension="872779008" root="1.3.6.1.4.1.519.1"/>
                        <name>MEDGEL PRIVATE LTD</name>
                     </assignedOrganization>
                     <performance>
                        <actDefinition>
                           <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="MANUFACTURE"/>
                           <product>
                              <manufacturedProduct classCode="MANU">
                                 <manufacturedMaterialKind>
                                    <code code="68210-0111" codeSystem="2.16.840.1.113883.6.69"/>
                                 </manufacturedMaterialKind>
                              </manufacturedProduct>
                           </product>
                        </actDefinition>
                     </performance>
                  </assignedEntity>
               </assignedOrganization>
            </assignedEntity>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section ID="DLDE">
               <id root="7b6104ac-4f74-43be-8bb6-4c613ffda0a6"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL PRODUCT DATA ELEMENTS SECTION"/>
               <effectiveTime value="20160804"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="68210-0111" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>ASSURED MAXIMUM STRENGTH MUCUS RELIEF</name>
                        <formCode code="C42936" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CAPSULE, GELATIN COATED"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="325" unit="mg"/>
                              <denominator value="1" unit="1"/>
                           </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 value="10" unit="mg"/>
                              <denominator value="1" unit="1"/>
                           </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 value="200" unit="mg"/>
                              <denominator value="1" unit="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="495W7451VQ" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>GUAIFENESIN</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="495W7451VQ" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>GUAIFENESIN</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="5" unit="mg"/>
                              <denominator value="1" unit="1"/>
                           </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="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="H77VEI93A8" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>FD&amp;C YELLOW NO. 6</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="2G86QN327L" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>GELATIN</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="B697894SGQ" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>POLYETHYLENE GLYCOL 400</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="U725QWY32X" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>POVIDONE K30</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="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>WATER</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="506T60A25R" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SORBITOL</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="15FIX9V2JP" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>TITANIUM DIOXIDE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="10" unit="1"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43168" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BLISTER PACK"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="1" unit="1"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="68210-0111-1" 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>
                                    <marketingAct>
                                       <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                       <statusCode code="active"/>
                                       <effectiveTime>
                                          <low value="20160812"/>
                                       </effectiveTime>
                                    </marketingAct>
                                 </subjectOf>
                              </asContent>
                           </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>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="part341" root="2.16.840.1.113883.3.149"/>
                           <code code="C73603" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OTC MONOGRAPH FINAL"/>
                           <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="20160812"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <characteristic classCode="OBS">
                           <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C48331" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORANGE" xsi:type="CE">
                              <originalText>LIGHT</originalText>
                           </value>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic classCode="OBS">
                           <code code="SPLSCORE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value value="1" xsi:type="INT"/>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic classCode="OBS">
                           <code code="SPLSHAPE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C48345" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OVAL" xsi:type="CE">
                              <originalText>oblong</originalText>
                           </value>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic classCode="OBS">
                           <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value unit="mm" value="21" xsi:type="PQ"/>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic classCode="OBS">
                           <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value xsi:type="ST">341</value>
                        </characteristic>
                     </subjectOf>
                     <consumedIn>
                        <substanceAdministration>
                           <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                        </substanceAdministration>
                     </consumedIn>
                  </manufacturedProduct>
               </subject>
            </section>
         </component>
         <component>
            <section>
               <id root="4f000985-fa44-497f-b5e9-20a0c95fb7e4"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold italics">Drug Facts</content>
                  </paragraph>
               </text>
               <effectiveTime value="20160804"/>
            </section>
         </component>
         <component>
            <section>
               <id root="d3036250-d665-48d2-b3cf-39ce35c5ad65"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <effectiveTime value="20160804"/>
               <component>
                  <section>
                     <id root="2aa3f697-530e-48ac-a5df-6c02f9e7772f"/>
                     <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
                     <text>
                        <table width="75%">
                           <col width="50%" align="left" valign="top"/>
                           <col width="50%" align="right" valign="top"/>
                           <thead>
                              <tr>
                                 <th styleCode="italics">Active ingredients (in each softgel)</th>
                                 <th styleCode="italics">Purpose</th>
                              </tr>
                           </thead>
                           <tbody>
                              <tr>
                                 <td>Acetaminophen 325 mg</td>
                                 <td>Pain reliever/fever reducer</td>
                              </tr>
                              <tr>
                                 <td>Dextromethorphan HBr 10 mg</td>
                                 <td>Cough suppressant</td>
                              </tr>
                              <tr>
                                 <td>Guaifenesin 200 mg</td>
                                 <td>Expectorant</td>
                              </tr>
                              <tr>
                                 <td>Phenylephrine HCl 5 mg</td>
                                 <td>Nasal decongestant</td>
                              </tr>
                           </tbody>
                        </table>
                     </text>
                     <effectiveTime value="20160804"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="e41919e6-e354-442c-9aa7-c51f9f71edae"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>Uses</title>
               <text>
                  <list listType="unordered" styleCode="Square">
                     <item>temporarily relieves these common cold and flu symptoms:<list listType="unordered" styleCode="Square">
                           <item>nasal congestion</item>
                           <item>headache</item>
                           <item>cough</item>
                           <item>minor aches and pains</item>
                           <item>sore throat</item>
                        </list>
                     </item>
                     <item>temporarily reduces fever</item>
                     <item>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive</item>
                  </list>
               </text>
               <effectiveTime value="20160804"/>
            </section>
         </component>
         <component>
            <section>
               <id root="9535c19d-1720-4732-b17c-535e54231d48"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>Warnings</title>
               <effectiveTime value="20160804"/>
               <component>
                  <section>
                     <id root="33f3bc99-4e88-438d-b4c6-e6be64b6ec25"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Liver warning</title>
                     <text>
                        <paragraph>This product contains acetaminophen. Severe liver damage may occur if you take</paragraph>
                        <list listType="unordered" styleCode="Square">
                           <item>more than 12 liquid gels in 24 hours, which is the maximum daily amount</item>
                           <item>with other drugs containing acetaminophen</item>
                           <item>3 or more alcoholic drinks daily while using this product</item>
                        </list>
                     </text>
                     <effectiveTime value="20160804"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="b6d18053-a398-428c-9f2f-6c401d2e813d"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Allergy alert</title>
                     <text>
                        <paragraph>Acetaminophen may cause severe skin reactions. Symptoms may include:</paragraph>
                        <list listType="unordered" styleCode="Square">
                           <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>
                     </text>
                     <effectiveTime value="20160804"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="01dce77d-4d74-468c-bed2-a7cd8d243b84"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Sore throat warning</title>
                     <text>
                        <paragraph>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="20160804"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="6dc450ad-69d3-4ad9-8859-8ad6b2bb9ea6"/>
                     <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" styleCode="Square">
                           <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="20160804"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="728f76e3-6e02-49b3-8724-71412365b43e"/>
                     <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" styleCode="Square">
                           <item>liver disease</item>
                           <item>heart disease</item>
                           <item>diabetes</item>
                           <item>high blood pressure</item>
                           <item>thyroid disease</item>
                           <item>trouble urinating due to an enlarged prostate gland</item>
                           <item>persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema</item>
                           <item>cough that occurs with too much phlegm (mucus)</item>
                        </list>
                     </text>
                     <effectiveTime value="20160804"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="93714e1d-5fc7-454e-be03-74e44829599e"/>
                     <code code="50568-5" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR/PHARMACIST SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Ask a doctor or pharmacist before use if you are</content> taking the blood thinning drug warfarin.</paragraph>
                     </text>
                     <effectiveTime value="20160804"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="04b9d4c8-af00-4d75-97d9-66c2fa173833"/>
                     <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">When using this product, do not use more than directed.</content>
                        </paragraph>
                     </text>
                     <effectiveTime value="20160804"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="a34ba914-bf12-49eb-bf39-294880bd5564"/>
                     <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" styleCode="Square">
                           <item>nervousness, dizziness, or sleeplessness occur</item>
                           <item>pain, nasal congestion, or cough gets worse or lasts more than 7 days</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>cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.</item>
                        </list>
                     </text>
                     <effectiveTime value="20160804"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="f4478d16-8fab-488a-a67f-51948f5b32bd"/>
                     <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">If pregnant or breast-feeding,</content> ask a health professional before use.</paragraph>
                     </text>
                     <effectiveTime value="20160804"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="b02e0ef3-2628-4e34-ad20-953afbf56dae"/>
                     <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Keep out of reach of children.</content>
                        </paragraph>
                     </text>
                     <effectiveTime value="20160804"/>
                  </section>
               </component>
               <component>
                  <section ID="overdose">
                     <id root="71da45bc-dce3-4834-a4c8-1228cbcbc3c8"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Overdose warning</title>
                     <text>
                        <paragraph>Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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="20160804"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="913d4e9b-829c-4ac2-8469-4d4e34da1d1b"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Directions</title>
               <text>
                  <list listType="unordered" styleCode="Square">
                     <item>
                        <content styleCode="bold">do not take more than directed (see <linkHtml href="#overdose">Overdose warning</linkHtml>)</content>
                     </item>
                     <item>do not take more than 12 liquid gels in any 24-hour period</item>
                     <item>adults and children 12 years of age and older: take 2 liquid gels every 4 hours</item>
                     <item>children under 12 years of age: do not use</item>
                  </list>
               </text>
               <effectiveTime value="20160804"/>
            </section>
         </component>
         <component>
            <section>
               <id root="795d56c4-bde5-4da7-94e0-6fbb23cc7691"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>Other information</title>
               <text>
                  <list listType="unordered" styleCode="Square">
                     <item>store between 20-25°C (68-77°F)</item>
                     <item>avoid excessive heat</item>
                  </list>
               </text>
               <effectiveTime value="20160804"/>
            </section>
         </component>
         <component>
            <section>
               <id root="8556f00b-4cbd-4c9a-81a0-79d38900ec2c"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>Inactive ingredients</title>
               <text>
                  <paragraph>FD&amp;C yellow no. 6, FD&amp;C red no.40, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, purified water</paragraph>
               </text>
               <effectiveTime value="20160804"/>
            </section>
         </component>
         <component>
            <section>
               <id root="97708737-1509-49d8-a434-363228b1b7c6"/>
               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <title>Questions or Comments?</title>
               <text>
                  <paragraph>Call <content styleCode="bold">1-888-333-9792</content>
                  </paragraph>
               </text>
               <effectiveTime value="20160804"/>
            </section>
         </component>
         <component>
            <section>
               <id root="ab77edb7-0b09-4b7a-9247-7b7d5fad9216"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>PRINCIPAL DISPLAY PANEL - 10 Softgel Blister Pack Carton</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">COMPARE TO</content> ACTIVE INGREDIENTS IN<br/>
                     <content styleCode="bold">MUCINEX<sup>®</sup> FAST-MAX<sup>®</sup> COLD, FLU &amp; SORE THROAT*</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold italics">ASSURED</content>™</paragraph>
                  <paragraph>
                     <content styleCode="bold">MAXIMUM STRENGTH</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Mucus Relief</content>
                  </paragraph>
                  <list listType="unordered" styleCode="Disc">
                     <item>
                        <content styleCode="bold">Acetaminophen 325 mg</content>
                        <list listType="unordered">
                           <item>
                              <caption>-</caption>
                              <content styleCode="italics">Pain Reliever / Fever Reducer</content>
                           </item>
                        </list>
                     </item>
                     <item>
                        <content styleCode="bold">Dextromethorphan HBr 10 mg</content> - <content styleCode="italics">Cough Suppressant</content>
                     </item>
                     <item>
                        <content styleCode="bold">Guaifenesin 200 mg</content> - <content styleCode="italics">Expectorant</content>
                     </item>
                     <item>
                        <content styleCode="bold">Phenylephrine HCl 5 mg</content> - <content styleCode="italics">Nasal Decongestant</content>
                     </item>
                  </list>
                  <paragraph>
                     <content styleCode="bold italics">Thins &amp; Loosens Mucus,<br/>Nasal Congestion,<br/>Coughing, Fever &amp; Headache<br/>Non-Drowsy</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Actual Size</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">AGES 12+<br/>10 softgels</content>
                  </paragraph>
                  <renderMultiMedia referencedObject="MM1"/>
               </text>
               <effectiveTime value="20160804"/>
               <component>
                  <observationMedia ID="MM1">
                     <text>PRINCIPAL DISPLAY PANEL - 10 Softgel Blister Pack Carton</text>
                     <value xsi:type="ED" mediaType="image/jpeg">
                        <reference value="assured-01.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>