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  <title>IMODIUM
 <br/>
    <br/>
A-D
</title>
  <effectiveTime value="20250923"/>
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  <versionNumber value="10"/>
  <author>
    <time/>
    <assignedEntity>
      <representedOrganization>
        <id extension="118772437" root="1.3.6.1.4.1.519.1"/>
        <name>Kenvue Brands LLC</name>
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          <assignedOrganization/>
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          <effectiveTime value="20250923"/>
          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
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                <name>Imodium<suffix>A-D</suffix>
                </name>
                <formCode code="C42986" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SOLUTION"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Loperamide Hydrochloride</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="K679OBS311" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM</name>
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                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="T9D99G2B1R" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>CARAMEL</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="35SW5USQ3G" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>D&amp;C YELLOW NO. 10</name>
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                </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="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>GLYCERIN</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="OP1R32D61U" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>MICROCRYSTALLINE CELLULOSE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="6DC9Q167V3" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>PROPYLENE GLYCOL</name>
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                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="OJ245FE5EU" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SODIUM BENZOATE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="96K6UQ3ZD4" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SUCRALOSE</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="IACT">
                  <ingredientSubstance>
                    <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>WATER</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="TTV12P4NEE" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>XANTHAN GUM</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="mg" value="1"/>
                    <denominator unit="mL" value="7.5"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="77TI35393C" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>LOPERAMIDE HYDROCHLORIDE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="6X9OC3H4II" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>LOPERAMIDE</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>
                <asContent>
                  <quantity>
                    <numerator unit="mL" value="120"/>
                    <denominator value="1"/>
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                  <containerPackagedProduct>
                    <code code="50580-134-04" codeSystem="2.16.840.1.113883.6.69"/>
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                        <low value="20040701"/>
                      </effectiveTime>
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                  <quantity>
                    <numerator unit="mL" value="120"/>
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                    <characteristic>
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                    </characteristic>
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                  <subjectOf>
                    <marketingAct>
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                      <statusCode code="active"/>
                      <effectiveTime>
                        <low value="20040701"/>
                      </effectiveTime>
                    </marketingAct>
                  </subjectOf>
                </asContent>
                <asContent>
                  <quantity>
                    <numerator unit="mL" value="240"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code code="50580-134-08" codeSystem="2.16.840.1.113883.6.69"/>
                    <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
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                    <characteristic>
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                      </effectiveTime>
                    </marketingAct>
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                </asContent>
              </manufacturedProduct>
              <subjectOf>
                <approval>
                  <id extension="NDA019487" root="2.16.840.1.113883.3.150"/>
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                  <author>
                    <territorialAuthority>
                      <territory>
                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                      </territory>
                    </territorialAuthority>
                  </author>
                </approval>
              </subjectOf>
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                  <statusCode code="active"/>
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                    <low value="20040701"/>
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              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
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                  <value code="C48329" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="green" xsi:type="CE">
                    <originalText>opaque</originalText>
                  </value>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLFLAVOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
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                    <originalText/>
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              </subjectOf>
              <consumedIn>
                <substanceAdministration>
                  <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                </substanceAdministration>
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      <component>
        <section>
          <id root="daf73f04-740c-3bbf-e053-2a95a90ac408"/>
          <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="20200709"/>
        </section>
      </component>
      <component>
        <section>
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          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>Active ingredient (in each 7.5 mL)</title>
          <text>
            <paragraph>Loperamide HCl 1 mg</paragraph>
          </text>
          <effectiveTime value="20200709"/>
        </section>
      </component>
      <component>
        <section>
          <id root="daf73f04-740e-3bbf-e053-2a95a90ac408"/>
          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <title>Purpose</title>
          <text>
            <paragraph>Anti-diarrheal</paragraph>
          </text>
          <effectiveTime value="20200709"/>
        </section>
      </component>
      <component>
        <section>
          <id root="daf73f04-740f-3bbf-e053-2a95a90ac408"/>
          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>Use</title>
          <text>
            <paragraph>controls symptoms of diarrhea, including Travelers' Diarrhea</paragraph>
          </text>
          <effectiveTime value="20200709"/>
        </section>
      </component>
      <component>
        <section>
          <id root="daf73f04-7410-3bbf-e053-2a95a90ac408"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <effectiveTime value="20200709"/>
          <component>
            <section>
              <id root="daf73f04-7411-3bbf-e053-2a95a90ac408"/>
              <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
              <title>Allergy alert</title>
              <text>
                <paragraph>Do not use if you have ever had a rash or other allergic reaction to loperamide HCl</paragraph>
              </text>
              <effectiveTime value="20200709"/>
            </section>
          </component>
          <component>
            <section>
              <id root="daf73f04-7412-3bbf-e053-2a95a90ac408"/>
              <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
              <title>Heart alert</title>
              <text>
                <paragraph>Taking more than directed can cause serious heart problems or death</paragraph>
              </text>
              <effectiveTime value="20200709"/>
            </section>
          </component>
          <component>
            <section>
              <id root="daf73f04-7413-3bbf-e053-2a95a90ac408"/>
              <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 have bloody or black stool
        

 </paragraph>
              </text>
              <effectiveTime value="20200709"/>
            </section>
          </component>
          <component>
            <section>
              <id root="daf73f04-7414-3bbf-e053-2a95a90ac408"/>
              <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>fever</item>
                  <item>mucus in the stool</item>
                  <item>a history of liver disease</item>
                  <item>a history of abnormal heart rhythm</item>
                </list>
              </text>
              <effectiveTime value="20200709"/>
            </section>
          </component>
          <component>
            <section>
              <id root="daf73f04-7415-3bbf-e053-2a95a90ac408"/>
              <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 a prescription drug. Loperamide may interact with certain prescription drugs.
        

 </paragraph>
              </text>
              <effectiveTime value="20200709"/>
            </section>
          </component>
          <component>
            <section>
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              <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</content> tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
        

 </paragraph>
              </text>
              <effectiveTime value="20200709"/>
            </section>
          </component>
          <component>
            <section>
              <id root="daf73f04-7417-3bbf-e053-2a95a90ac408"/>
              <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>symptoms get worse</item>
                  <item>diarrhea lasts for more than 2 days</item>
                  <item>you get abdominal swelling or bulging. These may be signs of a serious condition.</item>
                </list>
              </text>
              <effectiveTime value="20200709"/>
            </section>
          </component>
          <component>
            <section>
              <id root="daf73f04-7418-3bbf-e053-2a95a90ac408"/>
              <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="20200709"/>
            </section>
          </component>
          <component>
            <section>
              <id root="daf73f04-7419-3bbf-e053-2a95a90ac408"/>
              <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 or contact a Poison Control Center right away. (1-800-222-1222)
        

 </paragraph>
              </text>
              <effectiveTime value="20200709"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section>
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          <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">drink plenty of clear fluids to help prevent dehydration caused by diarrhea</content>
              </item>
              <item>find right dose on chart. If possible, use weight to dose; otherwise use age.</item>
              <item>shake well before using</item>
              <item>use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.</item>
              <item>mL = milliliter</item>
            </list>
            <table styleCode="Noautorules" width="50%">
              <col align="left" valign="top" width="30%"/>
              <col align="left" valign="top" width="70%"/>
              <tbody>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule Toprule">adults and children 12 years and over</td>
                  <td styleCode="Toprule">30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours</td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule">children 9-11 years (60-95 lbs)</td>
                  <td>15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours</td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule">children 6-8 years (48-59 lbs)</td>
                  <td>15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours</td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule">children 2-5 years (34 to 47 lbs)</td>
                  <td>ask a doctor</td>
                </tr>
                <tr>
                  <td styleCode="Rrule">children under 2 years (up to 33 lbs)</td>
                  <td>do not use</td>
                </tr>
              </tbody>
            </table>
          </text>
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        </section>
      </component>
      <component>
        <section>
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          <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>each 30 mL contains: 
        
  
   <content styleCode="bold">sodium 16 mg</content>
              </item>
              <item>store between 20-25°C (68-77°F)</item>
              <item>
                <content styleCode="bold">do not use if outer neck band imprinted with "Imodium®" or inner neck band imprinted with "Sealed For Your Safety" is broken or missing</content>
              </item>
            </list>
          </text>
          <effectiveTime value="20200709"/>
        </section>
      </component>
      <component>
        <section>
          <id root="daf73f04-741c-3bbf-e053-2a95a90ac408"/>
          <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, caramel color, D&amp;C yellow no. 10, FD&amp;C blue no. 1, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum</paragraph>
          </text>
          <effectiveTime value="20200709"/>
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      </component>
      <component>
        <section>
          <id root="daf73f04-741d-3bbf-e053-2a95a90ac408"/>
          <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">1-877-895-3665</content> (toll-free) or 
       
 
  <content styleCode="bold">215-273-8755</content> (collect)
      

 </paragraph>
          </text>
          <effectiveTime value="20200709"/>
        </section>
      </component>
      <component>
        <section ID="id_link_daf9ff98-038b-f7e4-e053-2995a90a6373">
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          <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>NDC 50580-134-08</paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Imodium 
   <sup>®</sup>
                <br/>
A-D
  </content>
              <br/>
              <br/>
Loperamide HCl Oral Solution
 </paragraph>
            <paragraph>Anti-Diarrheal
  <br/>
1 mg per 7.5 mL
 </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Anti-Diarrheal</content>
              <br/>
Oral Solution
 </paragraph>
            <paragraph/>
            <paragraph>Controls the symptoms</paragraph>
            <paragraph>of diarrhea</paragraph>
            <paragraph/>
            <paragraph>8 fl oz
  <br/>
(240 mL)
 </paragraph>
            <paragraph/>
            <paragraph>Mint Flavor</paragraph>
            <paragraph>
              <renderMultiMedia referencedObject="img_daf91e77-8f1e-4296-e053-2995a90af858"/>
            </paragraph>
          </text>
          <effectiveTime value="20200709"/>
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              <text>imodium-01</text>
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