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  <title>Childrens Benadryl Allergy Plus Congestion</title>
  <effectiveTime value="20241108"/>
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        <name>Kenvue Brands LLC</name>
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                <name>Childrens Benadryl Allergy Plus Congestion</name>
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                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Diphenhydramine hydrochloride and Phenylephrine 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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                  <ingredientSubstance>
                    <code code="K679OBS311" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="7FLD91C86K" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>EDETATE DISODIUM</name>
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                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="H3R47K3TBD" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>FD&amp;C BLUE NO. 1</name>
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                <ingredient classCode="IACT">
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                    <code code="WZB9127XOA" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>FD&amp;C RED NO. 40</name>
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                  <ingredientSubstance>
                    <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>GLYCERIN</name>
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                    <name>SORBITOL SOLUTION</name>
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                    <name>DIPHENHYDRAMINE HYDROCHLORIDE</name>
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                    <code code="04JA59TNSJ" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>PHENYLEPHRINE HYDROCHLORIDE</name>
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                        <code code="1WS297W6MV" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>PHENYLEPHRINE</name>
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                    <numerator unit="mL" value="118"/>
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                            <low value="20140930"/>
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                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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          <text>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">Drug Facts</content>
              </content>
            </paragraph>
          </text>
          <effectiveTime value="20210225"/>
        </section>
      </component>
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          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <effectiveTime value="20210225"/>
          <component>
            <section>
              <id root="f795dd02-2920-d691-e053-6294a90a88e0"/>
              <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
              <text>
                <table width="60%">
                  <col align="left" valign="top" width="50%"/>
                  <col align="right" valign="top" width="50%"/>
                  <thead>
                    <tr>
                      <th>
                        <content styleCode="italics">Active ingredients (in each 5 mL)</content>
                      </th>
                      <th>
                        <content styleCode="italics">Purposes</content>
                      </th>
                    </tr>
                  </thead>
                  <tbody>
                    <tr>
                      <td>Diphenhydramine HCl 12.5 mg</td>
                      <td>Antihistamine</td>
                    </tr>
                    <tr>
                      <td>Phenylephrine HCl 5 mg</td>
                      <td>Nasal decongestant</td>
                    </tr>
                  </tbody>
                </table>
              </text>
              <effectiveTime value="20210225"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section>
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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>nasal congestion</item>
                  <item>stuffy nose</item>
                </list>
              </item>
              <item>temporarily relieves these symptoms due to the common cold:
        
  
   <list listType="unordered" styleCode="Square">
                  <item>runny nose</item>
                  <item>sneezing</item>
                  <item>nasal congestion</item>
                  <item>stuffy nose</item>
                </list>
              </item>
              <item>temporarily relieves sinus congestion and pressure</item>
            </list>
          </text>
          <effectiveTime value="20210225"/>
        </section>
      </component>
      <component>
        <section>
          <id root="f795dd02-2922-d691-e053-6294a90a88e0"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <effectiveTime value="20210225"/>
          <component>
            <section>
              <id root="f795dd02-2923-d691-e053-6294a90a88e0"/>
              <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>
                  <item>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.</item>
                </list>
              </text>
              <effectiveTime value="20210225"/>
            </section>
          </component>
          <component>
            <section>
              <id root="f795dd02-2924-d691-e053-6294a90a88e0"/>
              <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>heart disease</item>
                  <item>high blood pressure</item>
                  <item>thyroid disease</item>
                  <item>diabetes</item>
                  <item>trouble urinating due to an enlarged prostate gland</item>
                  <item>a breathing problem such as emphysema or chronic bronchitis</item>
                  <item>glaucoma</item>
                </list>
              </text>
              <effectiveTime value="20210225"/>
            </section>
          </component>
          <component>
            <section>
              <id root="f795dd02-2925-d691-e053-6294a90a88e0"/>
              <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 sedatives or tranquilizers
        

 </paragraph>
              </text>
              <effectiveTime value="20210225"/>
            </section>
          </component>
          <component>
            <section>
              <id root="f795dd02-2926-d691-e053-6294a90a88e0"/>
              <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>
                    <content styleCode="bold">do not exceed recommended dose</content>
                  </item>
                  <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="20210225"/>
            </section>
          </component>
          <component>
            <section>
              <id root="f795dd02-2927-d691-e053-6294a90a88e0"/>
              <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>nervousness, dizziness, or sleeplessness occur</item>
                  <item>symptoms do not improve within 7 days or occur with a fever</item>
                </list>
              </text>
              <effectiveTime value="20210225"/>
            </section>
          </component>
          <component>
            <section>
              <id root="f795dd02-2928-d691-e053-6294a90a88e0"/>
              <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="20210225"/>
            </section>
          </component>
          <component>
            <section>
              <id root="f795dd02-2929-d691-e053-6294a90a88e0"/>
              <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="20210225"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section>
          <id root="f795dd02-292a-d691-e053-6294a90a88e0"/>
          <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 hours</item>
              <item>do not take more than 6 doses in 24 hours</item>
            </list>
            <table styleCode="Noautorules" width="60%">
              <col align="left" valign="top" width="55%"/>
              <col align="left" valign="top" width="45%"/>
              <thead>
                <tr styleCode="Botrule">
                  <th styleCode="Toprule Rrule">Age (yr)</th>
                  <th styleCode="Toprule">Dose (mL)</th>
                </tr>
              </thead>
              <tbody>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule">children under 4 years</td>
                  <td>do not use</td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule">children 4 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>5 mL</td>
                </tr>
                <tr>
                  <td styleCode="Rrule">adults and children 12 years and over</td>
                  <td>10 mL</td>
                </tr>
              </tbody>
            </table>
            <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="20210225"/>
        </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 5 mL contains: 								
        
  
   <content styleCode="bold"> sodium 10 mg</content>
              </item>
              <item>store between 20-25°C (68-77°F)</item>
              <item>
                <content styleCode="bold">do not use if carton tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing</content>
              </item>
            </list>
          </text>
          <effectiveTime value="20210225"/>
        </section>
      </component>
      <component>
        <section>
          <id root="f795dd02-292c-d691-e053-6294a90a88e0"/>
          <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, carboxymethylcellulose sodium, edetate disodium, FD&amp;C blue no. 1, FD&amp;C red no. 40, flavors, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose</paragraph>
          </text>
          <effectiveTime value="20210225"/>
        </section>
      </component>
      <component>
        <section>
          <id root="f795dd02-292d-d691-e053-6294a90a88e0"/>
          <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> (toll-free) or 
       
 
  <content styleCode="bold">215-273-8755</content> (collect)
      

 </paragraph>
          </text>
          <effectiveTime value="20210225"/>
        </section>
      </component>
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        <section>
          <id root="f795dd02-292e-d691-e053-6294a90a88e0"/>
          <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 50580-341-01</paragraph>
            <paragraph>Children's
       
 
  <br/>Benadryl
       
 
  <sup>®</sup>
            </paragraph>
            <paragraph>ALLERGY PLUS
       
 
  <br/>CONGESTION
      

 </paragraph>
            <paragraph>Diphenhydramine HCl / antihistamine
       
 
  <br/> Phenylephrine HCl / nasal decongestant
       
 
  <br/> oral solution
      

 </paragraph>
            <paragraph>4 Hours/Dose</paragraph>
            <paragraph>RELIEF OF:</paragraph>
            <list listType="unordered">
              <item>Runny Nose
       </item>
              <item>Sneezing
       </item>
              <item>Itchy, Watery Eyes
       </item>
              <item>Itchy Throat or Nose
       </item>
              <item>Sinus Congestion
       </item>
              <item>Stuffy Nose
       </item>
            </list>
            <paragraph>Alcohol Free
       
 
  <br/> Sugar Free
      

 </paragraph>
            <paragraph>ALLERGY + CONGESTION RELIEF</paragraph>
            <paragraph>Grape!
       
 
  <br/> Flavored Liquid
      

 </paragraph>
            <paragraph>4 fl oz (118 mL)</paragraph>
            <renderMultiMedia referencedObject="MM1"/>
          </text>
          <effectiveTime value="20210225"/>
          <component>
            <observationMedia ID="MM1">
              <text>Principal Display Panel</text>
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