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  <title>BENADRYL Allergy Oral Solution</title>
  <effectiveTime value="20250130"/>
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        <name>Kenvue Brands LLC</name>
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          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="50580-573" codeSystem="2.16.840.1.113883.6.69"/>
                <name>BENADRYL Allergy</name>
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                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Diphenhydramine hydrochloride</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="XF417D3PSL" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>ANHYDROUS CITRIC ACID</name>
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                    <code code="9DBA0SBB0L" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>D&amp;C RED NO. 33</name>
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                </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>
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                    <code code="TUF2IVW3M2" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POLOXAMER 407</name>
                  </ingredientSubstance>
                </ingredient>
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                    <name>SODIUM CHLORIDE</name>
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                    <code code="1Q73Q2JULR" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SODIUM CITRATE, UNSPECIFIED FORM</name>
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                    <code code="C151H8M554" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SUCROSE</name>
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                </ingredient>
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                  <quantity>
                    <numerator unit="mg" value="12.5"/>
                    <denominator unit="mL" value="5"/>
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                    <code code="TC2D6JAD40" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>DIPHENHYDRAMINE HYDROCHLORIDE</name>
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                        <name>DIPHENHYDRAMINE</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
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                  <quantity>
                    <numerator unit="mL" value="118"/>
                    <denominator value="1"/>
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                        <numerator unit="1" value="1"/>
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                          <statusCode code="active"/>
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                            <low value="20241202"/>
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                  <author>
                    <territorialAuthority>
                      <territory>
                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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          <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="20240917"/>
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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 5 mL)</title>
          <text>
            <paragraph>Diphenhydramine HCl 12.5 mg</paragraph>
          </text>
          <effectiveTime value="20240917"/>
        </section>
      </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="20240917"/>
        </section>
      </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>
                  <item>temporarily relieves these symptoms due to the common cold:</item>
                </list>
              </item>
              <item>runny nose</item>
              <item>sneezing</item>
            </list>
          </text>
          <effectiveTime value="20240917"/>
        </section>
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          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <effectiveTime value="20240917"/>
          <component>
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              <id root="224df6e9-a138-8856-e063-6394a90afbb3"/>
              <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="20240917"/>
            </section>
          </component>
          <component>
            <section ID="id_link_224e0bd0-7f5a-f8a7-e063-6394a90ab159">
              <id root="224e0bd0-7f59-f8a7-e063-6394a90ab159"/>
              <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
              <title>Ask a doctor before use if the user has</title>
              <text>
                <list listType="unordered" styleCode="Square">
                  <item>a breathing problem such as chronic bronchitis</item>
                  <item>glaucoma</item>
                  <item>trouble urinating due to an enlarged prostate gland</item>
                  <item>a sodium-restricted diet</item>
                </list>
              </text>
              <effectiveTime value="20240917"/>
            </section>
          </component>
          <component>
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              <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 the user is </content> taking sedatives or tranquilizers
 </paragraph>
              </text>
              <effectiveTime value="20240917"/>
            </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 alcoholic 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="20240917"/>
            </section>
          </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 health professional before use.
 </paragraph>
              </text>
              <effectiveTime value="20240917"/>
            </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="20240917"/>
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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>mL = milliliter</item>
              <item>take every 4 to 6 hours, or as directed by a doctor</item>
              <item>do not take more than 6 doses in 24 hours</item>
            </list>
            <table border="0" width="100%">
              <tbody>
                <tr>
                  <td>
                    <content styleCode="bold">Age (yr)</content>
                  </td>
                  <td>
                    <content styleCode="bold">Dose (mL)</content>
                  </td>
                </tr>
                <tr>
                  <td>adults and children
     <br/>
			12 years and over
    </td>
                  <td>10 mL to 20 mL (2x10 mL;
     <br/>
			Note: dosing cup needs to
     <br/>
			be filled to 10 mL line twice
     <br/>
			for the 20 mL dose)
    </td>
                </tr>
                <tr>
                  <td>children 6 to 11 years</td>
                  <td>5 mL to 10 mL</td>
                </tr>
                <tr>
                  <td>children 2 to 5 years</td>
                  <td>do not use unless directed
     <br/>
			by a doctor
    </td>
                </tr>
                <tr>
                  <td>children under 2 years</td>
                  <td>do not use</td>
                </tr>
              </tbody>
            </table>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Attention: </content>use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
 </paragraph>
          </text>
          <effectiveTime value="20240917"/>
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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>
            <paragraph>■ each 5 mL contains:
  <content styleCode="bold"> sodium 14 mg</content>
              <br/>
■ store between 20-25ºC (68-77ºF). Protect from light. Store in outer carton until contents used.
  <br/>
■
  <content styleCode="bold"> do not use if carton is opened
   <br/>
■ do not use if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing
  </content>
            </paragraph>
          </text>
          <effectiveTime value="20240917"/>
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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>anhydrous citric acid, D&amp;C red no. 33, FD&amp;C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose</paragraph>
          </text>
          <effectiveTime value="20240917"/>
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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 (collect)</content>
            </paragraph>
          </text>
          <effectiveTime value="20240917"/>
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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 50580-573-04</paragraph>
            <paragraph>NEW DOSING FOR ADULTS
  <br/>
              <br/>
Benadryl 
  <sup>®</sup>
            </paragraph>
            <paragraph>ALLERGY</paragraph>
            <paragraph>LIQUID</paragraph>
            <paragraph>Diphenhydramine HCl/antihistamine
  <br/>
12.5 mg/5 mL oral solution
 </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>Same as Children’s Benadryl® Allergy Liquid</paragraph>
            <paragraph/>
            <list listType="unordered">
              <item>Sneezing</item>
              <item>Runny Nose</item>
              <item>Itchy, Watery Eyes</item>
              <item>Itchy Throat or Nose</item>
            </list>
            <paragraph/>
            <paragraph>Alcohol Free</paragraph>
            <paragraph/>
            <paragraph>Wild Cherry</paragraph>
            <paragraph>Flavored Liquid</paragraph>
            <paragraph/>
            <paragraph>4 fl oz (118 mL)</paragraph>
            <paragraph>
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            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph/>
          </text>
          <effectiveTime value="20240917"/>
          <component>
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              <text>benadryl-1</text>
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