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  <title>Imodium A-D</title>
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                <name>Imodium A-D</name>
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                    <name>POLYOXYL 40 HYDROGENATED CASTOR OIL</name>
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                  <ingredientSubstance>
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          <text>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">Drug Facts</content>
              </content>
            </paragraph>
          </text>
          <effectiveTime value="20200406"/>
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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 capsule)</title>
          <text>
            <paragraph>Loperamide HCl 2 mg</paragraph>
          </text>
          <effectiveTime value="20200406"/>
        </section>
      </component>
      <component>
        <section>
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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>Anti-diarrheal</paragraph>
          </text>
          <effectiveTime value="20200406"/>
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      </component>
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          <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="20200406"/>
        </section>
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          <title>Warnings</title>
          <text>
            <paragraph>
              <content styleCode="bold">Allergy alert: </content>Do not use if you have ever had a rash or other allergic reaction to loperamide HCl
 </paragraph>
            <paragraph>
              <content styleCode="bold">Heart alert:</content> Taking more than directed can cause serious heart problems or death
 </paragraph>
            <paragraph>
              <content styleCode="bold">Do not use</content>
            </paragraph>
            <list listType="unordered">
              <item>if you have bloody or black stool</item>
              <item>in children under 12 years of age</item>
            </list>
            <paragraph>
              <content styleCode="bold">Ask a doctor before use if you have</content>
            </paragraph>
            <list listType="unordered">
              <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>
            <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>
            <paragraph>
              <content styleCode="bold">When using this product </content>tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.
 </paragraph>
            <paragraph>
              <content styleCode="bold">Stop use and ask a doctor if </content>
            </paragraph>
            <list listType="unordered">
              <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>
            <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.
 </paragraph>
          </text>
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              <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="20200406"/>
            </section>
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              <title>Heart alert</title>
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                <paragraph>Taking more than directed can cause serious heart problems or death</paragraph>
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              <effectiveTime value="20200406"/>
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              <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
              <title>Do not use</title>
              <text>
                <list listType="unordered" styleCode="Square">
                  <item>if you have bloody or black stool</item>
                  <item>in children under 12 years of age</item>
                </list>
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          </component>
          <component>
            <section>
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              <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="20200406"/>
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          <component>
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              <id root="cfa46d02-bb31-bc6d-e053-2995a90a3a59"/>
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              <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="20200406"/>
            </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="20200406"/>
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          </component>
          <component>
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              <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="20200406"/>
            </section>
          </component>
          <component>
            <section>
              <id root="cfa46d02-bb34-bc6d-e053-2995a90a3a59"/>
              <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="20200406"/>
            </section>
          </component>
          <component>
            <section>
              <id root="cfa46d02-bb35-bc6d-e053-2995a90a3a59"/>
              <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.
        

 </paragraph>
              </text>
              <effectiveTime value="20200406"/>
            </section>
          </component>
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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>
                <content styleCode="bold">not for use in children under 12 years of age</content>
              </item>
              <item>adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours</item>
            </list>
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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>store at 20°-25°C (68°-77°F). Protect from light.</item>
              <item>avoid excessive heat above 40°C (104°F)</item>
              <item>
                <content styleCode="bold">do not use if blister unit is torn or broken</content>
              </item>
            </list>
          </text>
          <effectiveTime value="20200406"/>
        </section>
      </component>
      <component>
        <section>
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          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>Inactive ingredients</title>
          <text>
            <paragraph>butylated hydroxyanisole, edible ink, FD&amp;C blue no. 1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water</paragraph>
          </text>
          <effectiveTime value="20200406"/>
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        <section>
          <id root="cfa46d02-bb39-bc6d-e053-2995a90a3a59"/>
          <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="20200406"/>
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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 50580-367-02</paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Imodium 
   <sup>®</sup>
                <br/>
                <br/>
A-D
  </content>
              <br/>
              <br/>
Loperamide HCl, 2mg/Anti-Diarrheal
  <br/>
              <br/>
Soft Gelatin Capsules
 </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Anti-Diarrheal
   <br/>
Softgels
  </content>
            </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Controls the symptoms
   <br/>
of diarrhea
  </content>
            </paragraph>
            <paragraph/>
            <paragraph>Suitable for adults and
  <br/>
              <br/>
children 12 years and over
 </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">24 Softgels*</content>
              <br/>
              <br/>
Actual Size
 </paragraph>
            <paragraph>*each liquid-filled capsule contains 2 mg loperamide HCl</paragraph>
            <paragraph>
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          <effectiveTime value="20200406"/>
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              <text>imodium-01</text>
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