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  <title>ZYRTEC-D</title>
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        <name>Kenvue Brands LLC</name>
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          <subject>
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                <name>ZYRTEC-D</name>
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                <asEntityWithGeneric>
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                    <name>Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride</name>
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                    <name>MICROCRYSTALLINE CELLULOSE</name>
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                    <code code="3WJQ0SDW1A" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POLYETHYLENE GLYCOL, UNSPECIFIED</name>
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                    <name>TITANIUM DIOXIDE</name>
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                    <numerator unit="mg" value="5"/>
                    <denominator unit="1" value="1"/>
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                    <name>CETIRIZINE HYDROCHLORIDE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="YO7261ME24" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>CETIRIZINE</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="mg" value="120"/>
                    <denominator unit="1" value="1"/>
                  </quantity>
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                    <code code="6V9V2RYJ8N" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>PSEUDOEPHEDRINE HYDROCHLORIDE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="7CUC9DDI9F" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>PSEUDOEPHEDRINE</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
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                  <quantity>
                    <numerator unit="1" value="6"/>
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                    <code/>
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                        <numerator unit="1" value="4"/>
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                <approval>
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                    <territorialAuthority>
                      <territory>
                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value xsi:type="ST">ZYRTEC;D</value>
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              </subjectOf>
              <consumedIn>
                <substanceAdministration>
                  <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
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      <component>
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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="20230111"/>
        </section>
      </component>
      <component>
        <section ID="id_link_f1fd5ac5-428b-ebaf-e053-2995a90ac7e7">
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          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <effectiveTime value="20230111"/>
          <component>
            <section>
              <id root="ce2ccd3c-7241-1164-e053-2a95a90abb5b"/>
              <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
              <text>
                <table width="65%">
                  <col align="left" valign="top" width="65%"/>
                  <col align="right" valign="top" width="35%"/>
                  <thead>
                    <tr>
                      <th>
                        <content styleCode="bold">
                          <content styleCode="italics">Active ingredients (in each extended release tablet)</content>
                        </content>
                      </th>
                      <th>
                        <content styleCode="bold">
                          <content styleCode="italics">Purpose</content>
                        </content>
                      </th>
                    </tr>
                  </thead>
                  <tbody>
                    <tr>
                      <td>Cetirizine HCl 5 mg</td>
                      <td>Antihistamine</td>
                    </tr>
                    <tr>
                      <td>Pseudoephedrine HCl 120 mg</td>
                      <td>Nasal decongestant</td>
                    </tr>
                  </tbody>
                </table>
              </text>
              <effectiveTime value="20170929"/>
            </section>
          </component>
        </section>
      </component>
      <component>
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          <id root="f1fd728c-8880-41ac-e053-2a95a90a7542"/>
          <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>
                </list>
              </item>
              <item>reduces swelling of nasal passages</item>
              <item>temporarily relieves sinus congestion and pressure</item>
              <item>temporarily restores freer breathing through the nose</item>
            </list>
          </text>
          <effectiveTime value="20230111"/>
        </section>
      </component>
      <component>
        <section ID="id_link_f1fd5ac5-428d-ebaf-e053-2995a90ac7e7">
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          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <effectiveTime value="20230111"/>
          <component>
            <section>
              <id root="ce2ccd3c-7244-1164-e053-2a95a90abb5b"/>
              <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 ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.</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="20170929"/>
            </section>
          </component>
          <component>
            <section>
              <id root="ce2ccd3c-7245-1164-e053-2a95a90abb5b"/>
              <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>thyroid disease</item>
                  <item>diabetes</item>
                  <item>glaucoma</item>
                  <item>high blood pressure</item>
                  <item>trouble urinating due to an enlarged prostate gland</item>
                  <item>liver or kidney disease. Your doctor should determine if you need a different dose.</item>
                </list>
              </text>
              <effectiveTime value="20170929"/>
            </section>
          </component>
          <component>
            <section>
              <id root="ce2ccd3c-7246-1164-e053-2a95a90abb5b"/>
              <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="20170929"/>
            </section>
          </component>
          <component>
            <section>
              <id root="ce2ccd3c-7247-1164-e053-2a95a90abb5b"/>
              <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 use more than directed</content>
                  </item>
                  <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="20170929"/>
            </section>
          </component>
          <component>
            <section>
              <id root="ce2ccd3c-7248-1164-e053-2a95a90abb5b"/>
              <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>an allergic reaction to this product occurs. Seek medical help right away.</item>
                  <item>you get nervous, dizzy, or sleepless</item>
                  <item>symptoms do not improve within 7 days or are accompanied by fever</item>
                </list>
              </text>
              <effectiveTime value="20170929"/>
            </section>
          </component>
          <component>
            <section>
              <id root="ce2ccd3c-7249-1164-e053-2a95a90abb5b"/>
              <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>
                </paragraph>
                <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="20170929"/>
            </section>
          </component>
          <component>
            <section>
              <id root="ce2ccd3c-724a-1164-e053-2a95a90abb5b"/>
              <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="20170929"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section ID="id_link_f1fd5ac5-428f-ebaf-e053-2995a90ac7e7">
          <id root="f1fd5ac5-428e-ebaf-e053-2995a90ac7e7"/>
          <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>do not break or chew tablet; swallow tablet whole</item>
            </list>
            <table styleCode="Noautorules" width="60%">
              <colgroup>
                <col align="left" valign="top" width="50%"/>
                <col align="left" valign="top" width="50%"/>
              </colgroup>
              <tbody>
                <tr styleCode="Botrule">
                  <td styleCode="Rrule Toprule">adults and children 12 years and over</td>
                  <td styleCode="Toprule">take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.</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 12 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="20230111"/>
        </section>
      </component>
      <component>
        <section ID="id_link_f1fd4d42-eea7-c7b4-e053-2995a90a418d">
          <id root="f1fda07f-e1f6-2be6-e053-2995a90a4c05"/>
          <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 between 20° to 25°C (68° to 77°F)</item>
              <item>
                <content styleCode="bold">do not use if blister unit is torn or broken</content>
              </item>
            </list>
          </text>
          <effectiveTime value="20230111"/>
        </section>
      </component>
      <component>
        <section ID="id_link_f1fd4d42-eea9-c7b4-e053-2995a90a418d">
          <id root="f1fd4d42-eea8-c7b4-e053-2995a90a418d"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>Inactive ingredients</title>
          <text>
            <paragraph>colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide</paragraph>
          </text>
          <effectiveTime value="20230111"/>
        </section>
      </component>
      <component>
        <section ID="id_link_f1fd5ac5-4291-ebaf-e053-2995a90ac7e7">
          <id root="f1fd5ac5-4290-ebaf-e053-2995a90ac7e7"/>
          <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="20230111"/>
        </section>
      </component>
      <component>
        <section ID="id_link_f1fd5ac5-4287-ebaf-e053-2995a90ac7e7">
          <id root="4ec61c5b-80dc-a1a2-e063-6394a90a0d68"/>
          <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/>
            <paragraph/>
            <paragraph/>
            <paragraph/>
            <paragraph>NDC 50580-719-24</paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">ZYRTEC-D 
    <sup>®</sup>
                </content>
              </content>
            </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="italics">Cetirizine HCl</content>
              <content styleCode="bold">5 mg</content>/antihistamine
  <br/>
Pseudoephedrine HCl 
  <content styleCode="bold">120 mg</content>/
  <content styleCode="italics">nasal decongestant
   <br/>
Extended Release Tablets 
  </content>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph/>
            <paragraph>Indoor &amp;</paragraph>
            <paragraph>Outdoor</paragraph>
            <paragraph>Allergies</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph/>
            <paragraph/>
            <paragraph>ALLERGY</paragraph>
            <paragraph>+ SINUS</paragraph>
            <paragraph>NASAL CONGESTION</paragraph>
            <paragraph>+ SINUS PRESSURE</paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">12
    <br/>
Hour
   </content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">relief of</content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">• Sneezing </content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">• Runny Nose </content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">• Itchy, Watery Eyes </content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">• Itchy Throat or Nose</content>
              </content>
            </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph/>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">Actual Size</content>
              </content>
            </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">24
    <br/>
EXTENDED 
   </content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">RELEASE </content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">TABLETS</content>
              </content>
            </paragraph>
            <paragraph>
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