<?xml version="1.0" encoding="UTF-8" standalone="no"?><?xml-stylesheet href="../../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 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
  <id root="292d319c-6fbf-8ada-e063-6294a90a0c79"/>
  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <title>Cough Relief Softgels</title>
  <effectiveTime value="20241213"/>
  <setId root="e8959420-f597-439a-abd1-ca1c0413669a"/>
  <versionNumber value="6"/>
  <author>
    <time/>
    <assignedEntity>
      <representedOrganization>
        <id extension="179621011" root="1.3.6.1.4.1.519.1"/>
        <name>Spirit Pharmaceuticals LLC</name>
      </representedOrganization>
    </assignedEntity>
  </author>
  <component>
    <structuredBody>
      <component>
        <section>
          <id root="292d3c04-c677-3dc0-e063-6394a90ac61d"/>
          <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="68210-4133" 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="6DC9Q167V3" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>PROPYLENE GLYCOL</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="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>WATER</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="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="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="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 unit="1" value="15"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code/>
                    <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                    <asContent>
                      <quantity>
                        <numerator unit="1" value="1"/>
                        <denominator value="1"/>
                      </quantity>
                      <containerPackagedProduct>
                        <code code="68210-4133-1" 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="20210428"/>
                          </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="20210428"/>
                  </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;904</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="c109cddc-e372-3c5c-e053-2a95a90a455a"/>
          <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="20210428"/>
        </section>
      </component>
      <component>
        <section>
          <id root="c109cddc-e373-3c5c-e053-2a95a90a455a"/>
          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>Active ingredient (in each liquid-filled capsule)</title>
          <text>
            <paragraph>Dextromethorphan HBr, USP 15mg</paragraph>
          </text>
          <effectiveTime value="20210428"/>
        </section>
      </component>
      <component>
        <section>
          <id root="c109cddc-e374-3c5c-e053-2a95a90a455a"/>
          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <title>Purpose</title>
          <text>
            <paragraph>Cough suppressant</paragraph>
          </text>
          <effectiveTime value="20210428"/>
        </section>
      </component>
      <component>
        <section>
          <id root="c109cddc-e375-3c5c-e053-2a95a90a455a"/>
          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>Use</title>
          <text>
            <paragraph>temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.</paragraph>
          </text>
          <effectiveTime value="20210428"/>
        </section>
      </component>
      <component>
        <section>
          <id root="c109cddc-e376-3c5c-e053-2a95a90a455a"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <effectiveTime value="20210428"/>
          <component>
            <section>
              <id root="c109cddc-e377-3c5c-e053-2a95a90a455a"/>
              <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="20210428"/>
            </section>
          </component>
          <component>
            <section>
              <id root="c109cddc-e378-3c5c-e053-2a95a90a455a"/>
              <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>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>
                  <item>trouble urinating due to an enlarged prostate gland</item>
                </list>
              </text>
              <effectiveTime value="20210428"/>
            </section>
          </component>
          <component>
            <section>
              <id root="c109cddc-e379-3c5c-e053-2a95a90a455a"/>
              <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="20210428"/>
            </section>
          </component>
          <component>
            <section>
              <id root="c109cddc-e37a-3c5c-e053-2a95a90a455a"/>
              <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="20210428"/>
            </section>
          </component>
          <component>
            <section>
              <id root="c109cddc-e37b-3c5c-e053-2a95a90a455a"/>
              <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="20210428"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section>
          <id root="c109cddc-e37c-3c5c-e053-2a95a90a455a"/>
          <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>do not take more than 8 capsules 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 align="left" valign="top" width="50%"/>
              <col align="left" valign="top" width="50%"/>
              <tbody>
                <tr styleCode="Botrule">
                  <td styleCode="Lrule Rrule">adults and children 12 years and over</td>
                  <td styleCode="Rrule">take 2 capsules every 6 to 8 hours, as needed</td>
                </tr>
                <tr>
                  <td styleCode="Lrule Rrule">children under 12 years</td>
                  <td styleCode="Rrule">do not use</td>
                </tr>
              </tbody>
            </table>
          </text>
          <effectiveTime value="20210428"/>
        </section>
      </component>
      <component>
        <section>
          <id root="c109cddc-e37d-3c5c-e053-2a95a90a455a"/>
          <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 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="20210428"/>
        </section>
      </component>
      <component>
        <section>
          <id root="c109cddc-e37e-3c5c-e053-2a95a90a455a"/>
          <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 blue no. 1, FD&amp;C red no. 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide</paragraph>
          </text>
          <effectiveTime value="20210428"/>
        </section>
      </component>
      <component>
        <section>
          <id root="c109cddc-e37f-3c5c-e053-2a95a90a455a"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>Questions or comments?</title>
          <text>
            <paragraph>
              <content styleCode="bold">1-888-333-9792</content>
            </paragraph>
          </text>
          <effectiveTime value="20210428"/>
        </section>
      </component>
      <component>
        <section ID="L02c28c1d-57b1-441b-9aef-2eb220e70166">
          <id root="fd664ad2-82ba-a507-e053-6294a90afc87"/>
          <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>Cough Relief</paragraph>
            <paragraph>Dextromethorphan HBr, 15 mg - Cough Suppressant
  <br/>
Relieves cough for up to 8 hours, Non-Drowsy
  <br/>
              <br/>
Adult Long Lasting
  <br/>
              <br/>
Ages 12+
 </paragraph>
            <paragraph>
              <br/>
15 Softgels
 </paragraph>
            <paragraph/>
            <paragraph>
              <renderMultiMedia referencedObject="img_fd666f5d-c4b9-f12f-e053-6394a90ac851"/>
            </paragraph>
            <paragraph/>
            <paragraph>
              <renderMultiMedia referencedObject="img_fd664ad2-82b9-a507-e053-6294a90afc87"/>
            </paragraph>
            <paragraph/>
            <paragraph/>
          </text>
          <effectiveTime value="20210428"/>
          <component>
            <observationMedia ID="img_fd666f5d-c4b9-f12f-e053-6394a90ac851">
              <text>Label</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="VH Cough Softgels 15ct_LBL.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="img_fd664ad2-82b9-a507-e053-6294a90afc87">
              <text>Carton</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="VH Cough Softgels 15ct_CTN-New logo-V.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
    </structuredBody>
  </component>
</document>