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  <title>Children's Benadryl 
 <sup>®</sup> Chewables
</title>
  <effectiveTime value="20241108"/>
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        <name>Kenvue Brands LLC</name>
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                    <name>diphenhydramine hydrochloride</name>
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          <text>
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              <content styleCode="bold">
                <content styleCode="italics">Drug Facts</content>
              </content>
            </paragraph>
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          <effectiveTime value="20160525"/>
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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 chewable tablet)</title>
          <text>
            <paragraph>Diphenhydramine HCl 12.5 mg</paragraph>
          </text>
          <effectiveTime value="20160525"/>
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      </component>
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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>Antihistamine</paragraph>
          </text>
          <effectiveTime value="20160525"/>
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      </component>
      <component>
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          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>Uses</title>
          <text>
            <list listType="unordered" styleCode="Square">
              <item>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 							
        
  
   <list listType="unordered" styleCode="Square">
                  <item>runny nose</item>
                  <item>sneezing</item>
                  <item>itchy, watery eyes</item>
                  <item>itching of the nose or throat</item>
                </list>
              </item>
            </list>
          </text>
          <effectiveTime value="20160525"/>
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          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
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          <effectiveTime value="20160525"/>
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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>to make a child sleepy</item>
                  <item>with any other product containing diphenhydramine, even one used on skin</item>
                </list>
              </text>
              <effectiveTime value="20160525"/>
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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>a breathing problem such as emphysema or chronic bronchitis</item>
                  <item>glaucoma</item>
                  <item>trouble urinating due to an enlarged prostate gland</item>
                </list>
              </text>
              <effectiveTime value="20160525"/>
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              <text>
                <paragraph>
                  <content styleCode="bold">Ask a doctor or pharmacist before use if you are</content> taking sedatives or tranquilizers
        

 </paragraph>
              </text>
              <effectiveTime value="20160525"/>
            </section>
          </component>
          <component>
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              <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
              <title>When using this product</title>
              <text>
                <list listType="unordered" styleCode="Square">
                  <item>marked drowsiness may occur</item>
                  <item>avoid alcohol drinks</item>
                  <item>alcohol, sedatives and tranquilizers may increase drowsiness</item>
                  <item>be careful when driving a motor vehicle or operating machinery</item>
                  <item>excitability may occur, especially in children</item>
                </list>
              </text>
              <effectiveTime value="20160525"/>
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          </component>
          <component>
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              <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 healthcare professional before use.
        

 </paragraph>
              </text>
              <effectiveTime value="20160525"/>
            </section>
          </component>
          <component>
            <section>
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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"/>
              <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="20160525"/>
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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>find right dose on chart below</item>
              <item>take every 4 to 6 hours, or as directed by a doctor</item>
              <item>do not take more than 6 times in 24 hours</item>
            </list>
            <table width="60%">
              <col align="left" valign="middle" width="35%"/>
              <col align="left" valign="middle" width="65%"/>
              <thead>
                <tr>
                  <th styleCode="Rrule">Age (yr)</th>
                  <th>Dose (chewable tablets)</th>
                </tr>
              </thead>
              <tbody>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule">children under 2 years</td>
                  <td>do not use</td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule">children 2 to 5 years</td>
                  <td>do not use unless directed by a doctor</td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule">children 6 to 11 years</td>
                  <td>1 to 2 chewable tablets (12.5 mg to 25 mg)</td>
                </tr>
                <tr>
                  <td styleCode="Rrule">adults and children 12 years and over</td>
                  <td>2 to 4 chewable tablets (25 mg to 50 mg)</td>
                </tr>
              </tbody>
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          <title>Other information</title>
          <text>
            <list listType="unordered" styleCode="Square">
              <item>store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.</item>
              <item>
                <content styleCode="bold">do not use if carton or blister unit is opened or broken/unsealed</content>
              </item>
              <item>see bottom panel for lot number and expiration date</item>
            </list>
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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>crospovidone, D&amp;C red no. 30 aluminum lake, D&amp;C red no. 7 calcium lake, dextrose excipient, ethylcellulose, FD&amp;C blue no. 1 aluminum lake, flavors, gum arabic, hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, sucralose, sugar spheres, tartaric acid</paragraph>
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          <effectiveTime value="20160525"/>
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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>call 
       
 
  <content styleCode="bold">1-877-717-2824</content> or 
       
 
  <content styleCode="bold">215-273-8755</content> (collect)
      

 </paragraph>
          </text>
          <effectiveTime value="20160525"/>
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        <section>
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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 50580-232-01</paragraph>
            <paragraph>
              <content styleCode="bold">Children's
        
  
   <br/>Benadryl
        
  
   <sup>®</sup>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">ALLERGY</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Diphenhydramine HCl/antihistamine 12.5 mg chewable tablets</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Chewables</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">4-6 Hours/Dose</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">RELIEF OF:</content>
            </paragraph>
            <list listType="unordered">
              <item>Runny Nose
       </item>
              <item>Sneezing
       </item>
              <item>Itchy, Watery Eyes
       </item>
              <item>Itchy Throat or Nose
       </item>
            </list>
            <paragraph>
              <content styleCode="bold">20
        
  
   <br/>Chewable Tablets
       
 
  </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Grape!</content>
              <br/>Flavored
       
 
  <br/>Tablets
      

 </paragraph>
            <paragraph>Actual Size</paragraph>
            <renderMultiMedia referencedObject="MM1"/>
          </text>
          <effectiveTime value="20160525"/>
          <component>
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              <text>PRINCIPAL DISPLAY PANEL</text>
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