<?xml version="1.0" encoding="UTF-8" standalone="no"?><?xml-stylesheet href="../../stylesheet/spl.xsl" type="text/xsl"?><document xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
  <id root="4bbb94e5-ada2-ab07-e063-6394a90a1b01"/>
  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <title>Cetirizine hydrochloride tablets USP 10 mg</title>
  <effectiveTime value="20260101"/>
  <setId root="f756d3b1-d2e4-3705-e053-6294a90aa380"/>
  <versionNumber value="4"/>
  <author>
    <time/>
    <assignedEntity>
      <representedOrganization>
        <id extension="036986393" root="1.3.6.1.4.1.519.1"/>
        <name>Northwind Health Company, LLC</name>
        <assignedEntity>
          <assignedOrganization>
            <id extension="036986393" root="1.3.6.1.4.1.519.1"/>
            <name>Northwind Health Company, LLC</name>
            <assignedEntity>
              <assignedOrganization>
                <id extension="036986393" root="1.3.6.1.4.1.519.1"/>
                <name>Northwind Health Company, LLC</name>
              </assignedOrganization>
              <performance>
                <actDefinition>
                  <code code="C73606" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="repack"/>
                  <product>
                    <manufacturedProduct classCode="MANU">
                      <manufacturedMaterialKind>
                        <code code="51655-842" codeSystem="2.16.840.1.113883.6.69"/>
                      </manufacturedMaterialKind>
                    </manufacturedProduct>
                  </product>
                </actDefinition>
              </performance>
            </assignedEntity>
          </assignedOrganization>
        </assignedEntity>
      </representedOrganization>
    </assignedEntity>
  </author>
  <component>
    <structuredBody>
      <component>
        <section>
          <id root="4c151e88-ccad-293b-e063-6294a90a8995"/>
          <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
          <effectiveTime value="20260101"/>
          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="51655-842" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Cetirizine Hydrochloride Tablets,10 mg</name>
                <formCode code="C42998" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TABLET"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Cetirizine Hydrochloride</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <asEquivalentEntity classCode="EQUIV">
                  <code code="C64637" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                  <definingMaterialKind>
                    <code code="49483-692" codeSystem="2.16.840.1.113883.6.69"/>
                  </definingMaterialKind>
                </asEquivalentEntity>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="15FIX9V2JP" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>TITANIUM DIOXIDE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="EWQ57Q8I5X" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>LACTOSE MONOHYDRATE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="O8232NY3SJ" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>STARCH, CORN</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="U725QWY32X" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POVIDONE K30</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="70097M6I30" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>MAGNESIUM STEARATE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="3NXW29V3WO" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>HYPROMELLOSES</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="3WJQ0SDW1A" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POLYETHYLENE GLYCOL, UNSPECIFIED</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="mg" value="10"/>
                    <denominator unit="1" value="1"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="64O047KTOA" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>CETIRIZINE HYDROCHLORIDE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="YO7261ME24" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>CETIRIZINE</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="90"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code code="51655-842-26" codeSystem="2.16.840.1.113883.6.69"/>
                    <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
                  </containerPackagedProduct>
                  <subjectOf>
                    <characteristic>
                      <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                      <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CV"/>
                    </characteristic>
                  </subjectOf>
                  <subjectOf>
                    <marketingAct>
                      <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                      <statusCode code="active"/>
                      <effectiveTime>
                        <low value="20230207"/>
                      </effectiveTime>
                    </marketingAct>
                  </subjectOf>
                </asContent>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="14"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code code="51655-842-84" codeSystem="2.16.840.1.113883.6.69"/>
                    <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
                  </containerPackagedProduct>
                  <subjectOf>
                    <characteristic>
                      <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                      <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CV"/>
                    </characteristic>
                  </subjectOf>
                  <subjectOf>
                    <marketingAct>
                      <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                      <statusCode code="active"/>
                      <effectiveTime>
                        <low value="20230310"/>
                      </effectiveTime>
                    </marketingAct>
                  </subjectOf>
                </asContent>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="100"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code code="51655-842-60" codeSystem="2.16.840.1.113883.6.69"/>
                    <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
                  </containerPackagedProduct>
                  <subjectOf>
                    <characteristic>
                      <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                      <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CV"/>
                    </characteristic>
                  </subjectOf>
                  <subjectOf>
                    <marketingAct>
                      <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                      <statusCode code="active"/>
                      <effectiveTime>
                        <low value="20230330"/>
                      </effectiveTime>
                    </marketingAct>
                  </subjectOf>
                </asContent>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="30"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code code="51655-842-52" codeSystem="2.16.840.1.113883.6.69"/>
                    <formCode code="C43173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE, PLASTIC"/>
                  </containerPackagedProduct>
                  <subjectOf>
                    <characteristic>
                      <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                      <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CV"/>
                    </characteristic>
                  </subjectOf>
                  <subjectOf>
                    <marketingAct>
                      <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                      <statusCode code="active"/>
                      <effectiveTime>
                        <low value="20230407"/>
                      </effectiveTime>
                    </marketingAct>
                  </subjectOf>
                </asContent>
              </manufacturedProduct>
              <subjectOf>
                <approval>
                  <id extension="ANDA078933" root="2.16.840.1.113883.3.150"/>
                  <code code="C73584" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ANDA"/>
                  <author>
                    <territorialAuthority>
                      <territory>
                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
                      </territory>
                    </territorialAuthority>
                  </author>
                </approval>
              </subjectOf>
              <subjectOf>
                <marketingAct>
                  <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                  <statusCode code="active"/>
                  <effectiveTime>
                    <low value="20230207"/>
                  </effectiveTime>
                </marketingAct>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value xsi:type="ST">J;220</value>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLSHAPE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value code="C48347" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="RECTANGLE" xsi:type="CE">
                    <originalText>Rounded-off rectangular shaped</originalText>
                  </value>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value unit="mm" value="9" xsi:type="PQ"/>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value code="C48325" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="white" xsi:type="CE">
                    <originalText>White to off white</originalText>
                  </value>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLSCORE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value value="1" xsi:type="INT"/>
                </characteristic>
              </subjectOf>
              <consumedIn>
                <substanceAdministration>
                  <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                </substanceAdministration>
              </consumedIn>
            </manufacturedProduct>
          </subject>
        </section>
      </component>
      <component>
        <section ID="id_link_d78f6adc-af37-7c8a-e053-2a95a90af8fb">
          <id root="4bbb871a-cd6c-9870-e063-6394a90a0189"/>
          <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
          <title>DRUG FACTS</title>
          <effectiveTime value="20220209"/>
        </section>
      </component>
      <component>
        <section ID="id_link_d78f787a-340b-7cd6-e053-2995a90ab9ea">
          <id root="4bbb871a-cd6d-9870-e063-6394a90a0189"/>
          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <text>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">Active ingredient (in each tablet)</content>
              </content>
              <br/>  Cetirizine HCl 10 mg 
  <br/>
            </paragraph>
          </text>
          <effectiveTime value="20220209"/>
        </section>
      </component>
      <component>
        <section ID="id_link_d78f6adc-af39-7c8a-e053-2a95a90af8fb">
          <id root="4bbb871a-cd6e-9870-e063-6394a90a0189"/>
          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <text>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">Purpose</content>
              </content>
              <br/>  Antihistamine 
  <br/>
              <br/>
            </paragraph>
          </text>
          <effectiveTime value="20220209"/>
        </section>
      </component>
      <component>
        <section ID="id_link_d78f787a-340d-7cd6-e053-2995a90ab9ea">
          <id root="4bbb871a-cd6f-9870-e063-6394a90a0189"/>
          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <text>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">Uses</content>
              </content>
            </paragraph>
            <paragraph>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 
  <br/>  • runny nose 
  <br/>  • sneezing 
  <br/>  • itchy, watery eyes 
  <br/>  • itching of the nose or throat 
  <br/>
            </paragraph>
          </text>
          <effectiveTime value="20220209"/>
        </section>
      </component>
      <component>
        <section ID="id_link_d78f787a-340f-7cd6-e053-2995a90ab9ea">
          <id root="4bbb871a-cd70-9870-e063-6394a90a0189"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <text>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">Warnings</content>
              </content>
            </paragraph>
          </text>
          <effectiveTime value="20220209"/>
          <component>
            <section ID="id_link_d78f787a-3411-7cd6-e053-2995a90ab9ea">
              <id root="4bbb871a-cd71-9870-e063-6394a90a0189"/>
              <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="20220209"/>
            </section>
          </component>
          <component>
            <section ID="id_link_d78f83c4-2209-8969-e053-2995a90a4a09">
              <id root="4bbb871a-cd72-9870-e063-6394a90a0189"/>
              <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. Your doctor should determine if you need a different dose.

 </paragraph>
              </text>
              <effectiveTime value="20220209"/>
            </section>
          </component>
          <component>
            <section ID="id_link_d78f8425-641c-e84a-e053-2995a90a56a8">
              <id root="4bbb871a-cd73-9870-e063-6394a90a0189"/>
              <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>
                <paragraph/>
              </text>
              <effectiveTime value="20220209"/>
            </section>
          </component>
          <component>
            <section ID="id_link_d78f787a-3414-7cd6-e053-2995a90ab9ea">
              <id root="4bbb871a-cd74-9870-e063-6394a90a0189"/>
              <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">When using this product:</content>
                  <br/>  • drowsiness may occur 
  <br/>  • avoid alcoholic drinks 
  <br/>  • alcohol, sedatives, and tranquilizers may increase drowsiness 
  <br/>  • be careful when driving a motor vehicle or operating machinery 
  <br/>
                </paragraph>
              </text>
              <effectiveTime value="20220209"/>
            </section>
          </component>
          <component>
            <section ID="id_link_d78f8425-641e-e84a-e053-2995a90a56a8">
              <id root="4bbb871a-cd75-9870-e063-6394a90a0189"/>
              <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="20220209"/>
            </section>
          </component>
          <component>
            <section ID="id_link_d78f83c4-220b-8969-e053-2995a90a4a09">
              <id root="4bbb871a-cd76-9870-e063-6394a90a0189"/>
              <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>
                  <br/>  • if breast-feeding: Not recommended 
  <br/>  • if pregnant: Ask a health professional before use 
  <br/>
                </paragraph>
              </text>
              <effectiveTime value="20220209"/>
            </section>
          </component>
          <component>
            <section ID="id_link_d78f8425-6421-e84a-e053-2995a90a56a8">
              <id root="4bbb871a-cd77-9870-e063-6394a90a0189"/>
              <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>
                <paragraph/>
              </text>
              <effectiveTime value="20220209"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section ID="id_link_d78fa5f5-4e47-6f1b-e053-2995a90ac3aa">
          <id root="4bbb871a-cd78-9870-e063-6394a90a0189"/>
          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <text>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">Directions</content>
              </content>
            </paragraph>
            <table border="0" width="100%">
              <tbody>
                <tr>
                  <td>adults and children 6 years and over</td>
                  <td>one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.</td>
                </tr>
                <tr>
                  <td>adults 65 years and over</td>
                  <td>ask a doctor</td>
                </tr>
                <tr>
                  <td>children under 6 years of age</td>
                  <td>ask a doctor</td>
                </tr>
                <tr>
                  <td>consumers with liver or kidney disease</td>
                  <td>ask a doctor</td>
                </tr>
              </tbody>
            </table>
            <paragraph/>
          </text>
          <effectiveTime value="20220209"/>
        </section>
      </component>
      <component>
        <section ID="id_link_d78fa8d7-117e-0863-e053-2a95a90afec1">
          <id root="4bbb871a-cd79-9870-e063-6394a90a0189"/>
          <code code="60561-8" codeSystem="2.16.840.1.113883.6.1" displayName="OTHER SAFETY INFORMATION"/>
          <text>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">Other information</content>
              </content>
            </paragraph>
            <paragraph>• store between 20° to 25°C (68° to 77°F).</paragraph>
          </text>
          <effectiveTime value="20220209"/>
        </section>
      </component>
      <component>
        <section ID="id_link_d78f83c4-220d-8969-e053-2995a90a4a09">
          <id root="4bbb871a-cd7a-9870-e063-6394a90a0189"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <text>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">Inactive ingredients</content>
              </content>corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

 </paragraph>
          </text>
          <effectiveTime value="20220209"/>
        </section>
      </component>
      <component>
        <section ID="id_link_d78fa5f5-4e49-6f1b-e053-2995a90ac3aa">
          <id root="4bbb871a-cd7b-9870-e063-6394a90a0189"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <text>
            <paragraph>
              <content styleCode="italics">
                <content styleCode="bold">Questions or comments?</content>
              </content>
            </paragraph>
            <paragraph>Call
 
  <content styleCode="bold">1-877-290-4008</content>
            </paragraph>
          </text>
          <effectiveTime value="20220209"/>
        </section>
      </component>
      <component>
        <section ID="id_link_4c155124-86eb-5923-e063-6294a90aa479">
          <id root="4c155124-86ea-5923-e063-6294a90aa479"/>
          <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">NDC:  51655-842-60</content>
            </paragraph>
            <paragraph>
              <renderMultiMedia referencedObject="img_4c155071-de10-6db3-e063-6294a90a5338"/>
            </paragraph>
          </text>
          <effectiveTime value="20260101"/>
          <component>
            <observationMedia ID="img_4c155071-de10-6db3-e063-6294a90a5338">
              <text>Label</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="51655-842-60 - Rev A 03-23 NHC.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
    </structuredBody>
  </component>
</document>