<?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="0019a922-379e-42b7-9443-8e313504ce1b"/>
  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <title>Tussin Cough DM  503</title>
  <effectiveTime value="20231229"/>
  <setId root="e25727d0-7dd7-4ef5-b064-7938679f075f"/>
  <versionNumber value="8"/>
  <author>
    <time/>
    <assignedEntity>
      <representedOrganization>
        <id extension="009830555" root="1.3.6.1.4.1.519.1"/>
        <name>Salado Sales, Inc.</name>
        <assignedEntity>
          <assignedOrganization>
            <id extension="790523323" root="1.3.6.1.4.1.519.1"/>
            <name>AptaPharma Inc.</name>
            <assignedEntity>
              <assignedOrganization>
                <id extension="790523323" root="1.3.6.1.4.1.519.1"/>
                <name>AptaPharma Inc.</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="57243-503" codeSystem="2.16.840.1.113883.6.69"/>
                      </manufacturedMaterialKind>
                    </manufacturedProduct>
                  </product>
                </actDefinition>
              </performance>
            </assignedEntity>
          </assignedOrganization>
        </assignedEntity>
      </representedOrganization>
    </assignedEntity>
  </author>
  <component>
    <structuredBody>
      <component>
        <section>
          <id root="927ea83c-7caf-4a07-95ec-fa29b177ebf1"/>
          <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL listing data elements section"/>
          <effectiveTime value="20231229"/>
          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="57243-503" codeSystem="2.16.840.1.113883.6.69"/>
                <name>TUSSIN COUGH<suffix>EXPECTORANT COUGH SUPRESSANT DM</suffix>
                </name>
                <formCode code="C42953" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="LIQUID"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="mg" value="10"/>
                    <denominator unit="mL" value="5"/>
                  </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="100"/>
                    <denominator unit="mL" value="5"/>
                  </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="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="IY9XDZ35W2" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>DEXTROSE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="WZB9127XOA" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>FD&amp;C RED NO. 40</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>GLYCERIN</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="XY6UN3QB6S" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>HIGH FRUCTOSE CORN SYRUP</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="L7T10EIP3A" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>MENTHOL</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="SB8ZUX40TY" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SACCHARIN SODIUM</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="OJ245FE5EU" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SODIUM BENZOATE</name>
                  </ingredientSubstance>
                </ingredient>
                <asContent>
                  <quantity>
                    <numerator unit="mL" value="118"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code code="57243-503-24" codeSystem="2.16.840.1.113883.6.69"/>
                    <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                  </containerPackagedProduct>
                  <subjectOf>
                    <marketingAct>
                      <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                      <statusCode code="active"/>
                      <effectiveTime>
                        <low value="20120101"/>
                      </effectiveTime>
                    </marketingAct>
                  </subjectOf>
                  <subjectOf>
                    <characteristic classCode="OBS">
                      <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="CE"/>
                    </characteristic>
                  </subjectOf>
                </asContent>
              </manufacturedProduct>
              <subjectOf>
                <marketingAct>
                  <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                  <statusCode code="active"/>
                  <effectiveTime>
                    <low value="20120101"/>
                  </effectiveTime>
                </marketingAct>
              </subjectOf>
              <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>
              <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="a3a4bdcc-a5b7-4af9-aff2-13a34e3b06a9"/>
          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>Drug FactsActive ingredients ( in each 5 mL tsp)
</title>
          <text>
            <paragraph>Dextromethorphan HBr, USP 10 mg<br/>
              <br/>Guaifenesin, USP 100 mg</paragraph>
          </text>
          <effectiveTime value="20170409"/>
        </section>
      </component>
      <component>
        <section>
          <id root="1087e6e2-dcee-4563-ac9e-5a95d83a2d84"/>
          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <title>Purpose</title>
          <text>
            <paragraph>Cough Suppressant<br/>Expectorant </paragraph>
          </text>
          <effectiveTime value="20170409"/>
        </section>
      </component>
      <component>
        <section>
          <id root="b783f011-6654-4cbe-84c3-ba7d80413796"/>
          <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>
              <content styleCode="bold">Keep out of reach of children.</content>
            </paragraph>
            <paragraph> In case of overdose, get medical help or contact a Poison Control Center right away</paragraph>
          </text>
          <effectiveTime value="20170409"/>
        </section>
      </component>
      <component>
        <section>
          <id root="565806e1-fc45-4a39-a77b-e705283a2c6c"/>
          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>Uses</title>
          <text>
            <list ID="idce1e04a-ed39-4bf7-87d1-b1d0a1db219c" listType="unordered">
              <item>temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold</item>
              <item>helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes</item>
            </list>
          </text>
          <effectiveTime value="20170409"/>
        </section>
      </component>
      <component>
        <section>
          <id root="dbd996c0-c481-400d-973f-bec8a005e784"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <text>
            <paragraph>
              <content styleCode="bold">Do not use</content>
            </paragraph>
            <list ID="i8e6dddca-5580-48be-8cfa-c2645a1fcbaa" listType="unordered">
              <item>in a child under 12 years of age</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="20170409"/>
        </section>
      </component>
      <component>
        <section>
          <id root="9c23e98e-557e-4a39-8215-6bd033a43f91"/>
          <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
          <title>Ask A Doctor Before You Use if You Have</title>
          <text>
            <list ID="i28a67f35-1bc6-439d-80aa-2ecff91cb812" listType="unordered">
              <item>cough that occurs with too much phlegm (mucus)</item>
              <item>cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema</item>
            </list>
          </text>
          <effectiveTime value="20170409"/>
        </section>
      </component>
      <component>
        <section>
          <id root="be10b0ae-4a99-46c8-9c1f-568fd3f84f8b"/>
          <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>
            <paragraph>cough lasts 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="20170409"/>
        </section>
      </component>
      <component>
        <section>
          <id root="65d17b67-24f7-440e-b2cb-6f881beb8eec"/>
          <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.<br/>
            </paragraph>
          </text>
          <effectiveTime value="20170409"/>
        </section>
      </component>
      <component>
        <section>
          <id root="2d124117-8b04-4d2e-a5e4-9257d134de34"/>
          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>Directions</title>
          <text>
            <list ID="i9e3b5baa-37f2-4d0a-890e-dab98b750c6b" listType="unordered">
              <item> do not take more than 6 doses in any 24-hour period</item>
            </list>
            <paragraph>Age                                       Dose</paragraph>
            <paragraph>adults &amp; children                     2 teaspoonfuls<br/>12 years and over                  every 4 hours</paragraph>
            <paragraph>children under 12 years           do not use</paragraph>
          </text>
          <effectiveTime value="20170409"/>
        </section>
      </component>
      <component>
        <section>
          <id root="d1375976-ab95-448e-977d-5fb1189c30df"/>
          <code code="60561-8" codeSystem="2.16.840.1.113883.6.1" displayName="OTHER SAFETY INFORMATION"/>
          <title>Other information</title>
          <text>
            <paragraph/>
            <list ID="i46665e06-c45a-4e50-81ec-99e83797ce9f" listType="unordered">
              <item>store at 20-25° C (66-77° F)</item>
              <item>do not refrigerate</item>
              <item>dosage cup provided</item>
              <item>sodium 3 mg per teaspoon</item>
            </list>
          </text>
          <effectiveTime value="20170409"/>
        </section>
      </component>
      <component>
        <section>
          <id root="9b189877-ae79-4a0b-8a63-456819bd042d"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>Inactive ingredients</title>
          <text>
            <paragraph>Anhydrous citric acid, dextrose, FD &amp; C red # 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate</paragraph>
          </text>
          <effectiveTime value="20170409"/>
        </section>
      </component>
      <component>
        <section>
          <id root="624fd17e-47d8-4e65-9660-8c367841a35b"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>Questions?</title>
          <text>
            <paragraph>Call weekdays from 9:30 AM to 4:30 PM EST at <br/>
            </paragraph>
            <paragraph>
              <content styleCode="bold">1-877-798-5944</content>
            </paragraph>
          </text>
          <effectiveTime value="20170409"/>
        </section>
      </component>
      <component>
        <section>
          <id root="dc5db6ce-f143-4d0f-824b-33a1d2f3b56d"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>Tussin Cough DM product label</title>
          <text>
            <paragraph>
              <content styleCode="bold">* COMPARE TO ROBITUSSIN® PEAK COLD ACTIVE INGREDIENTS</content>
            </paragraph>
            <paragraph>
              <br/>
              <content styleCode="bold">CVP® CONSUMER VALUE PRODUCTS</content>
              <br/>
              <br/>
              <content styleCode="bold">TUSSIN COUGH EXPECTORANT COUGH SUPPRESSANT DM</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">NON-DROWSY COUGH FORMULA</content>
            </paragraph>
            <paragraph/>
            <list ID="i31d9e62b-4dc5-4897-898e-2c500b381bdc" listType="unordered">
              <item>ADULT</item>
              <item>FOR AGES 12 AND OVER</item>
              <item>CONTROLS COUGH</item>
              <item>HELPS LOOSEN CHEST CONGESTION</item>
            </list>
            <paragraph>4 FL OZ (118 Ml)</paragraph>
            <paragraph>* This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin® Peak Cold</paragraph>
            <paragraph>Box-001 Rev 01</paragraph>
            <paragraph>
              <content styleCode="bold">DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING</content>
              <br/>
              <br/>Distributed by: Salado Sales, Inc.  P.O. Box 6115 Temple, TX 76503  www.saladosales.com</paragraph>
            <paragraph>LOT.</paragraph>
            <paragraph/>
            <paragraph>EXP.</paragraph>
            <paragraph>
              <renderMultiMedia referencedObject="La0ffa706-dfeb-4468-b418-052b9a9fda23"/>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <renderMultiMedia referencedObject="L983c7e3e-33ab-4440-9547-3ae64659fd8c"/>
            </paragraph>
            <paragraph>res</paragraph>
            <paragraph/>
            <paragraph>
              <renderMultiMedia referencedObject="La0ffa706-dfeb-4468-b418-052b9a9fda23"/>
            </paragraph>
            <paragraph>
              <renderMultiMedia referencedObject="L983c7e3e-33ab-4440-9547-3ae64659fd8c"/>
            </paragraph>
          </text>
          <effectiveTime value="20231229"/>
          <component>
            <observationMedia ID="La0ffa706-dfeb-4468-b418-052b9a9fda23">
              <text>AptaSS TussinDM 503</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="AptaPharmSS TussinDM 503.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="L983c7e3e-33ab-4440-9547-3ae64659fd8c">
              <text>AptaSS TussinDM 503 1</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="AptaPharmSS TussinDM 503 1.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
    </structuredBody>
  </component>
</document>