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  <title>ZYRTEC</title>
  <effectiveTime value="20241108"/>
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  <versionNumber value="13"/>
  <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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          <subject>
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              <manufacturedProduct>
                <code code="50580-779" codeSystem="2.16.840.1.113883.6.69"/>
                <name>ZYRTEC</name>
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                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Cetirizine Hydrochloride</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="2G86QN327L" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>GELATIN, UNSPECIFIED</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
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                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="3OWL53L36A" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>MANNITOL</name>
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                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="B697894SGQ" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POLYETHYLENE GLYCOL 400</name>
                  </ingredientSubstance>
                </ingredient>
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                  <ingredientSubstance>
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                  <ingredientSubstance>
                    <code code="55X04QC32I" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SODIUM HYDROXIDE</name>
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                    <code code="6O92ICV9RU" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SORBITAN</name>
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                    <name>CETIRIZINE HYDROCHLORIDE</name>
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                      <activeMoiety>
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                        <name>CETIRIZINE</name>
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                    <numerator unit="1" value="12"/>
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                <approval>
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                  <author>
                    <territorialAuthority>
                      <territory>
                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                      </territory>
                    </territorialAuthority>
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                </approval>
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                    <low value="20100208"/>
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                </marketingAct>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value code="C48330" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="yellow" xsi:type="CE">
                    <originalText>Clear</originalText>
                  </value>
                </characteristic>
              </subjectOf>
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                  <code code="SPLSCORE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value value="1" xsi:type="INT"/>
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                <characteristic classCode="OBS">
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                  <value unit="mm" value="14" xsi:type="PQ"/>
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                <characteristic classCode="OBS">
                  <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value xsi:type="ST">Z10</value>
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              <consumedIn>
                <substanceAdministration>
                  <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                </substanceAdministration>
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      <component>
        <section>
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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="20181211"/>
        </section>
      </component>
      <component>
        <section>
          <id root="ce2f55de-7cfe-6f9f-e053-2995a90a4814"/>
          <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>Cetirizine HCl 10 mg</paragraph>
          </text>
          <effectiveTime value="20181211"/>
        </section>
      </component>
      <component>
        <section>
          <id root="ce2f55de-7cff-6f9f-e053-2995a90a4814"/>
          <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="20181211"/>
        </section>
      </component>
      <component>
        <section>
          <id root="ce2f55de-7d00-6f9f-e053-2995a90a4814"/>
          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>Uses</title>
          <text>
            <paragraph>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:</paragraph>
            <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>
          </text>
          <effectiveTime value="20181211"/>
        </section>
      </component>
      <component>
        <section>
          <id root="ce2f55de-7d01-6f9f-e053-2995a90a4814"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <effectiveTime value="20181211"/>
          <component>
            <section>
              <id root="ce2f55de-7d02-6f9f-e053-2995a90a4814"/>
              <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 ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
        

 </paragraph>
              </text>
              <effectiveTime value="20181211"/>
            </section>
          </component>
          <component>
            <section>
              <id root="ce2f55de-7d03-6f9f-e053-2995a90a4814"/>
              <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">Ask a doctor before use if you have </content> liver or kidney disease.
        

 </paragraph>
                <paragraph>Your doctor should determine if you need a different dose.</paragraph>
              </text>
              <effectiveTime value="20181211"/>
            </section>
          </component>
          <component>
            <section>
              <id root="ce2f55de-7d04-6f9f-e053-2995a90a4814"/>
              <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 tranquilizers or sedatives.
        

 </paragraph>
              </text>
              <effectiveTime value="20181211"/>
            </section>
          </component>
          <component>
            <section>
              <id root="ce2f55de-7d05-6f9f-e053-2995a90a4814"/>
              <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>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>
                </list>
              </text>
              <effectiveTime value="20181211"/>
            </section>
          </component>
          <component>
            <section>
              <id root="ce2f55de-7d06-6f9f-e053-2995a90a4814"/>
              <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">Stop use and ask a doctor if</content> an allergic reaction to this product occurs. Seek medical help right away.
        

 </paragraph>
              </text>
              <effectiveTime value="20181211"/>
            </section>
          </component>
          <component>
            <section>
              <id root="ce2f55de-7d07-6f9f-e053-2995a90a4814"/>
              <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
              <title>If pregnant or breast-feeding</title>
              <text>
                <list listType="unordered" styleCode="Square">
                  <item>if breast-feeding: not recommended</item>
                  <item>if pregnant: ask a health professional before use.</item>
                </list>
              </text>
              <effectiveTime value="20181211"/>
            </section>
          </component>
          <component>
            <section>
              <id root="ce2f55de-7d08-6f9f-e053-2995a90a4814"/>
              <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="20181211"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section>
          <id root="ce2f55de-7d09-6f9f-e053-2995a90a4814"/>
          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>Directions</title>
          <text>
            <table width="90%">
              <col align="left" valign="top" width="40%"/>
              <col align="left" valign="top" width="60%"/>
              <tbody>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule">adults and children 6 years and over</td>
                  <td>one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms.</td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule">adults 65 years and over</td>
                  <td>ask a doctor</td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule">children under 6 years of age</td>
                  <td>ask a doctor</td>
                </tr>
                <tr>
                  <td styleCode="Rrule">consumers with liver or kidney disease</td>
                  <td>ask a doctor</td>
                </tr>
              </tbody>
            </table>
          </text>
          <effectiveTime value="20181211"/>
        </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>store at 20°-25°C (68°-77°F)</item>
              <item>avoid high humidity and excessive heat above 40°C (104°F)</item>
              <item>protect from light</item>
              <item>
                <content styleCode="bold">do not use if foil inner seal printed with "SAFETY SEAL®" is broken or missing</content>
              </item>
            </list>
          </text>
          <effectiveTime value="20181211"/>
        </section>
      </component>
      <component>
        <section>
          <id root="ce2f55de-7d0b-6f9f-e053-2995a90a4814"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>Inactive ingredients</title>
          <text>
            <paragraph>gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol</paragraph>
          </text>
          <effectiveTime value="20181211"/>
        </section>
      </component>
      <component>
        <section>
          <id root="ce2f55de-7d0c-6f9f-e053-2995a90a4814"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>Questions?</title>
          <text>
            <paragraph>call 
       
 
  <content styleCode="bold">1-800-343-7805</content> (toll-free) or 
       
 
  <content styleCode="bold">215-273-8755</content> (collect)
      

 </paragraph>
          </text>
          <effectiveTime value="20181211"/>
        </section>
      </component>
      <component>
        <section>
          <id root="ce2f55de-7d0d-6f9f-e053-2995a90a4814"/>
          <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>
              <content styleCode="bold">
                <content styleCode="italics">Original Prescription Strength</content>
              </content>
            </paragraph>
            <paragraph>NDC 50580-779-12</paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">ZYRTEC
        
   
    <sup>®</sup>
                  <br/>ALLERGY
       
  
   </content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">INDOOR + OUTDOOR
        
   
    <br/>ALLERGIES
       
  
   </content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">Cetirizine HCl/
        
   
    <br/>antihistamine
        
   
    <br/>10 mg capsules
       
  
   </content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">LIQUID
        
   
    <br/> GELS
       
  
   </content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">24
        
   
    <br/> HOUR
        
   
    <br/> RELIEF OF
       
  
   </content>
              </content>
            </paragraph>
            <list listType="unordered" styleCode="Disc">
              <item>
                <content styleCode="italics">Sneezing</content>
              </item>
              <item>
                <content styleCode="italics">Runny Nose</content>
              </item>
              <item>
                <content styleCode="italics">Itchy, Watery Eyes</content>
              </item>
              <item>
                <content styleCode="italics">Itchy Throat or Nose</content>
              </item>
            </list>
            <paragraph>
              <content styleCode="bold">(Actual Size)</content>
            </paragraph>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">12
         
   
    <br/> LIQUID GELS*
        
  
   </content>
                <br/> *LIQUID-FILLED CAPSULES
        
  
   <br/>
                <content styleCode="bold">10 mg each</content>
              </content>
            </paragraph>
            <renderMultiMedia referencedObject="MM1"/>
          </text>
          <effectiveTime value="20181211"/>
          <component>
            <observationMedia ID="MM1">
              <text>PRINCIPAL DISPLAY PANEL</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="zyrtec-01.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
    </structuredBody>
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