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      <representedOrganization>
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        <name>DXM Pharmacuetical, Inc.</name>
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            <name>DXM Pharmacuetical, Inc.</name>
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            <manufacturedProduct>
              <manufacturedProduct>
                <code code="71598-102" codeSystem="2.16.840.1.113883.6.69"/>
                <name>RoboCough</name>
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                  <genericMedicine>
                    <name>Dextromethorphan HBr</name>
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                    <name>STEVIA LEAF</name>
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                    <numerator unit="mg" value="30"/>
                    <denominator unit="mL" value="3"/>
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                    <code code="9D2RTI9KYH" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>DEXTROMETHORPHAN HYDROBROMIDE</name>
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                        <code code="7355X3ROTS" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>DEXTROMETHORPHAN</name>
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                    <numerator unit="mL" value="120"/>
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                        <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
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                          <statusCode code="active"/>
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                            <low value="20231001"/>
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                  <code code="C200263" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OTC Monograph Drug"/>
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                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>Active ingredient</title>
          <text>
            <paragraph>(in each 3 mL) (one dose) Dextromethrophan HBr, 30 mg</paragraph>
          </text>
          <effectiveTime value="20250110"/>
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          <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>
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          <title>Uses</title>
          <text>
            <list listType="unordered">
              <item>Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.</item>
            </list>
          </text>
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          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warning</title>
          <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>
            <paragraph>
              <content styleCode="bold">Ask a doctor before use if you have</content>
              <br/>  • a cough that is accompanied by excessive phlegm (mucus), or 
  <br/>  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

 </paragraph>
            <paragraph>
              <content styleCode="bold">Stop use and ask a doctor if</content>a cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

 </paragraph>
            <paragraph>
              <content styleCode="bold">If pregnant or breast-feeding</content>, ask a health professional before use.

 </paragraph>
            <paragraph>
              <content styleCode="bold">Keep out of reach of children</content>. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

 </paragraph>
            <paragraph/>
          </text>
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          <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
          <title/>
          <text>
            <paragraph/>
          </text>
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          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <text>
            <paragraph>
              <content styleCode="bold">Directions</content>
              <br/>  • do not exceed 120 milligrams (4 doses) in any 24-hour period 
  <br/>  • measure only 3 mL with dosing syringe provided 
  <br/>  • only use this product according to these directions

 </paragraph>
            <paragraph>
              <content styleCode="bold"> age dose</content>
            </paragraph>
            <paragraph> adults and children 12 years and over</paragraph>
            <paragraph> 3mL every 6 to 8 hours </paragraph>
            <paragraph> children under 12 years </paragraph>
            <paragraph> do not use</paragraph>
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          <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
          <title>Other information </title>
          <text>
            <paragraph>•
 
  <content styleCode="bold">TAMPER EVIDENT</content>: Do not use if seal on the bottle is broken. 
  <br/>  • store at 20-25°C (68-77°F). Do not refrigerate.

 </paragraph>
          </text>
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          <title>Inactive ingredients</title>
          <text>
            <paragraph>Citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, stevia, sucralose, sucrose</paragraph>
          </text>
          <effectiveTime value="20250101"/>
        </section>
      </component>
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          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>Questions or comments?</title>
          <text>
            <paragraph>833-289-7626 between 10 a.m. to 4 p.m. CST, Monday-Friday</paragraph>
          </text>
          <effectiveTime value="20250101"/>
        </section>
      </component>
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          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>Product label</title>
          <text>
            <paragraph>
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            </paragraph>
          </text>
          <effectiveTime value="20250109"/>
          <component>
            <observationMedia ID="L56332a1f-8314-430d-9513-e3dce5e4a360">
              <text>image description</text>
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                <reference value="Robocough 4oz LABEL grape-Fin-02.jpg"/>
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