<?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="292d3e11-ff81-09e5-e063-6394a90a0194"/>
   <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
   <title>VALUMEDS™ ADULT LONG-LASTING COUGH RELIEF</title>
   <effectiveTime value="20241213"/>
   <setId root="ac4d581b-4f09-40a0-a75f-d23d9c6fc0b9"/>
   <versionNumber value="8"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="179621011"/>
            <name>Spirit Pharmaceuticals LLC</name>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="292cb3de-d3c2-2d1f-e063-6294a90aeed0"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20241213"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="68210-0106" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>DEXTROMETHORPHAN HYDROBROMIDE</name>
                        <formCode code="C42954" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CAPSULE, LIQUID FILLED"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>DEXTROMETHORPHAN HYDROBROMIDE</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <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="6DC9Q167V3" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>PROPYLENE GLYCOL</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="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>GLYCERIN</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="506T60A25R" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SORBITOL</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="15FIX9V2JP" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>TITANIUM DIOXIDE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="mg" value="15"/>
                              <denominator unit="1" value="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>
                        <asContent>
                           <quantity>
                              <numerator value="15" unit="1"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="1" unit="1"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="68210-0106-1" 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="20180410"/>
                                       </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>
                        <asContent>
                           <quantity>
                              <numerator value="240" unit="1"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="1" unit="1"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="68210-0106-2" 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="20200312"/>
                                       </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="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="20180410"/>
                           </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="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/>
                           </value>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic classCode="OBS">
                           <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value unit="mm" value="13" 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">404</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="a0ab9824-5e45-6f8f-e053-2a95a90a72e6"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Drug Facts</content>
                     </content>
                  </paragraph>
               </text>
               <effectiveTime value="20180411"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a0ab9824-5e46-6f8f-e053-2a95a90a72e6"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>
                  <content styleCode="bold">Active ingredient (in each softgel)</content>
               </title>
               <text>
                  <paragraph>Dextromethorphan HBr, USP 15mg</paragraph>
               </text>
               <effectiveTime value="20180411"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a0ab9824-5e47-6f8f-e053-2a95a90a72e6"/>
               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <title>
                  <content styleCode="bold">Purpose</content>
               </title>
               <text>
                  <paragraph>Cough suppressant</paragraph>
               </text>
               <effectiveTime value="20180411"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a0ab9824-5e48-6f8f-e053-2a95a90a72e6"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>
                  <content styleCode="bold">Use</content>
               </title>
               <text>
                  <paragraph>temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.</paragraph>
               </text>
               <effectiveTime value="20180411"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a0ab9824-5e49-6f8f-e053-2a95a90a72e6"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>
                  <content styleCode="bold">Warnings</content>
               </title>
               <effectiveTime value="20180411"/>
               <component>
                  <section>
                     <id root="a0ab9824-5e4a-6f8f-e053-2a95a90a72e6"/>
                     <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Do not use</content> 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
        

 
        

 
        

 
        

 </paragraph>
                     </text>
                     <effectiveTime value="20180411"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="a0ab9824-5e4b-6f8f-e053-2a95a90a72e6"/>
                     <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
                     <title>
                        <content styleCode="bold">Ask a doctor before use if you have</content>
                     </title>
                     <text>
                        <list listType="unordered" styleCode="Square">
                           <item>a cough that occurs with too much phlegm (mucus)</item>
                           <item>a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema</item>
                        </list>
                     </text>
                     <effectiveTime value="20180411"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="a0ab9824-5e4c-6f8f-e053-2a95a90a72e6"/>
                     <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
                     <text>
                        <paragraph>
                           <content styleCode="bold">Stop use and ask doctor if</content> cough lasts for more  than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
        

 
        

 
        

 
        

 </paragraph>
                     </text>
                     <effectiveTime value="20180411"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="a0ab9824-5e4d-6f8f-e053-2a95a90a72e6"/>
                     <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="20180411"/>
                  </section>
               </component>
               <component>
                  <section>
                     <id root="a0ab9824-5e4e-6f8f-e053-2a95a90a72e6"/>
                     <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> In case of overdose, get medical help orcontact a Poison Control Center right away.
        

 
        

 
        

 
        

 </paragraph>
                     </text>
                     <effectiveTime value="20180411"/>
                  </section>
               </component>
            </section>
         </component>
         <component>
            <section>
               <id root="a0ab9824-5e4f-6f8f-e053-2a95a90a72e6"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>
                  <content styleCode="bold">Directions</content>
               </title>
               <text>
                  <list listType="unordered" styleCode="Square">
                     <item>do not take more than 8 softgels in any 24-hour period</item>
                     <item>this adult product is not intended for use in children under 12 years of age</item>
                  </list>
                  <table width="45%">
                     <col width="50%" align="left" valign="top"/>
                     <col width="50%" align="left" valign="top"/>
                     <tbody>
                        <tr styleCode="Botrule First">
                           <td align="left" styleCode="Lrule Rrule">adults and children 12 years and over</td>
                           <td align="left" styleCode="Rrule">take 2 capsules every 6 to 8 hours, as needed</td>
                        </tr>
                        <tr>
                           <td align="left" styleCode="Lrule Rrule">children under 12 years</td>
                           <td align="left" styleCode="Rrule">do not use</td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph/>
               </text>
               <effectiveTime value="20180411"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a0ab9824-5e50-6f8f-e053-2a95a90a72e6"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>
                  <content styleCode="bold">Other information</content>
               </title>
               <text>
                  <list listType="unordered" styleCode="Square">
                     <item>store at 20-25°C (68-77°F)</item>
                     <item>avoid excessive heat above 40°C (104°F)</item>
                     <item>protect from light</item>
                  </list>
               </text>
               <effectiveTime value="20180411"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a0ab9824-5e51-6f8f-e053-2a95a90a72e6"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>
                  <content styleCode="bold">Inactive ingredients</content>
               </title>
               <text>
                  <paragraph> FD&amp;C red no. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, sorbitol sorbitan, titanium dioxide</paragraph>
               </text>
               <effectiveTime value="20180411"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a0ab9824-5e52-6f8f-e053-2a95a90a72e6"/>
               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <title>
                  <content styleCode="bold">Questions or comments?</content>
               </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">1-888-333-9792</content>
                  </paragraph>
               </text>
               <effectiveTime value="20180411"/>
            </section>
         </component>
         <component>
            <section>
               <id root="a0ab9824-5e53-6f8f-e053-2a95a90a72e6"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>Distributed By: </paragraph>
                  <paragraph>SPIRIT PHARMACEUTICALS LLC.</paragraph>
                  <paragraph>RONKONKOMA, NY 11779</paragraph>
               </text>
               <effectiveTime value="20180411"/>
            </section>
         </component>
         <component>
            <section ID="Lf2df168f-3735-434f-a4e0-17afad93bb45">
               <id root="a0ab9824-5e54-6f8f-e053-2a95a90a72e6"/>
               <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>Compare to the Active Ingredient of
       
 
  <br/>ROBITUSSIN ® LONG ACTING COUGH GELS ©*
      

 </paragraph>
                  <paragraph>VALUMEDS™</paragraph>
                  <paragraph>ADULT LONG-LASTING
       
 
  <br/>Cough Relief FOR AGES 12 &amp; OVER
      

 </paragraph>
                  <paragraph>Dextromethorphan HBr, 15 mg</paragraph>
                  <paragraph>Cough suppressant</paragraph>
                  <paragraph>Relieves cough for up to 8 hours</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="L77ccdf0b-3ee3-47b8-8641-807b84323b2b"/>
                  </paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Ldfaab776-aad6-485e-96c1-1492221217d6"/>
                  </paragraph>
               </text>
               <effectiveTime value="20200312"/>
               <component>
                  <observationMedia ID="L77ccdf0b-3ee3-47b8-8641-807b84323b2b">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="DEXTROM 15CT.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="Ldfaab776-aad6-485e-96c1-1492221217d6">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="DEXTROM 240 CT_N.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>