<?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="cbb30ec0-aba7-4035-8f4a-a3e82b064857"/>
  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="Human OTC Drug Label"/>
  <title>Allergy Relief<br/> Cetirizine Hydrochloride Tablets USP, 5 mg and 10 mg<br/>
  </title>
  <effectiveTime value="20250731"/>
  <setId root="652b0c65-a3f2-4454-9cf2-51a3389282cc"/>
  <versionNumber value="13"/>
  <author>
    <time/>
    <assignedEntity>
      <representedOrganization>
        <id extension="925822975" root="1.3.6.1.4.1.519.1"/>
        <name>MARKSANS PHARMA LIMITED</name>
        <assignedEntity>
          <assignedOrganization>
            <assignedEntity>
              <assignedOrganization>
                <id extension="925822975" root="1.3.6.1.4.1.519.1"/>
                <name>MARKSANS PHARMA LIMITED</name>
              </assignedOrganization>
              <performance>
                <actDefinition>
                  <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="MANUFACTURE"/>
                  <product>
                    <manufacturedProduct classCode="MANU">
                      <manufacturedMaterialKind>
                        <code code="25000-160" codeSystem="2.16.840.1.113883.6.69"/>
                      </manufacturedMaterialKind>
                    </manufacturedProduct>
                  </product>
                </actDefinition>
              </performance>
              <performance>
                <actDefinition>
                  <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="MANUFACTURE"/>
                  <product>
                    <manufacturedProduct classCode="MANU">
                      <manufacturedMaterialKind>
                        <code code="25000-219" codeSystem="2.16.840.1.113883.6.69"/>
                      </manufacturedMaterialKind>
                    </manufacturedProduct>
                  </product>
                </actDefinition>
              </performance>
              <performance>
                <actDefinition>
                  <code code="C43360" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="MANUFACTURE"/>
                  <product>
                    <manufacturedProduct classCode="MANU">
                      <manufacturedMaterialKind>
                        <code code="25000-220" 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="877b8293-81ec-45e1-a958-bcc0fce3f0a1"/>
          <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL PRODUCT DATA ELEMENTS SECTION"/>
          <effectiveTime value="20250605"/>
          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="25000-219" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Cetirizine Hydrochloride Tablets, 5 mg<suffix/>
                </name>
                <formCode code="C42998" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TABLET"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Cetirizine Hydrochloride</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="mg" value="5"/>
                    <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>
                <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>HYPROMELLOSE, UNSPECIFIED</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="IACT">
                  <ingredientSubstance>
                    <code code="15FIX9V2JP" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>TITANIUM DIOXIDE</name>
                  </ingredientSubstance>
                </ingredient>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="30"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code/>
                    <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                    <asContent>
                      <quantity>
                        <numerator unit="1" value="1"/>
                        <denominator value="1"/>
                      </quantity>
                      <containerPackagedProduct>
                        <code code="25000-219-03" codeSystem="2.16.840.1.113883.6.69"/>
                        <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                      </containerPackagedProduct>
                      <subjectOf>
                        <marketingAct>
                          <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                          <statusCode code="active"/>
                          <effectiveTime>
                            <low value="20220113"/>
                          </effectiveTime>
                        </marketingAct>
                      </subjectOf>
                    </asContent>
                  </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>
                </asContent>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="100"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code/>
                    <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                    <asContent>
                      <quantity>
                        <numerator unit="1" value="1"/>
                        <denominator value="1"/>
                      </quantity>
                      <containerPackagedProduct>
                        <code code="25000-219-08" codeSystem="2.16.840.1.113883.6.69"/>
                        <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                      </containerPackagedProduct>
                      <subjectOf>
                        <marketingAct>
                          <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                          <statusCode code="active"/>
                          <effectiveTime>
                            <low value="20220113"/>
                          </effectiveTime>
                        </marketingAct>
                      </subjectOf>
                    </asContent>
                  </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>
                </asContent>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="1000"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code code="25000-219-14" codeSystem="2.16.840.1.113883.6.69"/>
                    <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                  </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="20220113"/>
                      </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="20220113"/>
                  </effectiveTime>
                </marketingAct>
              </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="CV">
                    <originalText>white to off white</originalText>
                  </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="CV">
                    <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="7" xsi:type="PQ"/>
                </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>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value xsi:type="ST">J219</value>
                </characteristic>
              </subjectOf>
              <consumedIn>
                <substanceAdministration>
                  <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                </substanceAdministration>
              </consumedIn>
            </manufacturedProduct>
          </subject>
          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="25000-220" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Cetirizine Hydrochloride Tablets, 10 mg<suffix/>
                </name>
                <formCode code="C42998" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TABLET"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Cetirizine Hydrochloride</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <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>
                <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>HYPROMELLOSE, UNSPECIFIED</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="IACT">
                  <ingredientSubstance>
                    <code code="15FIX9V2JP" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>TITANIUM DIOXIDE</name>
                  </ingredientSubstance>
                </ingredient>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="30"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code/>
                    <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                    <asContent>
                      <quantity>
                        <numerator unit="1" value="1"/>
                        <denominator value="1"/>
                      </quantity>
                      <containerPackagedProduct>
                        <code code="25000-220-03" codeSystem="2.16.840.1.113883.6.69"/>
                        <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                      </containerPackagedProduct>
                      <subjectOf>
                        <marketingAct>
                          <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                          <statusCode code="active"/>
                          <effectiveTime>
                            <low value="20220113"/>
                          </effectiveTime>
                        </marketingAct>
                      </subjectOf>
                    </asContent>
                  </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>
                </asContent>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="100"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code/>
                    <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                    <asContent>
                      <quantity>
                        <numerator unit="1" value="1"/>
                        <denominator value="1"/>
                      </quantity>
                      <containerPackagedProduct>
                        <code code="25000-220-08" codeSystem="2.16.840.1.113883.6.69"/>
                        <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                      </containerPackagedProduct>
                      <subjectOf>
                        <marketingAct>
                          <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                          <statusCode code="active"/>
                          <effectiveTime>
                            <low value="20220113"/>
                          </effectiveTime>
                        </marketingAct>
                      </subjectOf>
                    </asContent>
                  </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>
                </asContent>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="1000"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code code="25000-220-14" codeSystem="2.16.840.1.113883.6.69"/>
                    <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                  </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="20220113"/>
                      </effectiveTime>
                    </marketingAct>
                  </subjectOf>
                </asContent>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="7"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code/>
                    <formCode code="C43168" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BLISTER PACK"/>
                    <asContent>
                      <quantity>
                        <numerator unit="1" value="1"/>
                        <denominator value="1"/>
                      </quantity>
                      <containerPackagedProduct>
                        <code code="25000-220-78" codeSystem="2.16.840.1.113883.6.69"/>
                        <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                      </containerPackagedProduct>
                      <subjectOf>
                        <marketingAct>
                          <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                          <statusCode code="active"/>
                          <effectiveTime>
                            <low value="20230417"/>
                          </effectiveTime>
                        </marketingAct>
                      </subjectOf>
                    </asContent>
                  </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>
                </asContent>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="14"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code/>
                    <formCode code="C43168" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BLISTER PACK"/>
                    <asContent>
                      <quantity>
                        <numerator unit="1" value="1"/>
                        <denominator value="1"/>
                      </quantity>
                      <containerPackagedProduct>
                        <code code="25000-220-81" codeSystem="2.16.840.1.113883.6.69"/>
                        <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                      </containerPackagedProduct>
                      <subjectOf>
                        <marketingAct>
                          <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                          <statusCode code="active"/>
                          <effectiveTime>
                            <low value="20230721"/>
                          </effectiveTime>
                        </marketingAct>
                      </subjectOf>
                    </asContent>
                  </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>
                </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="20220113"/>
                  </effectiveTime>
                </marketingAct>
              </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="CV">
                    <originalText>white to off white</originalText>
                  </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="CV">
                    <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="SPLSCORE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value value="1" xsi:type="INT"/>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value xsi:type="ST">J220</value>
                </characteristic>
              </subjectOf>
              <consumedIn>
                <substanceAdministration>
                  <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                </substanceAdministration>
              </consumedIn>
            </manufacturedProduct>
          </subject>
          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="25000-160" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)<suffix/>
                </name>
                <formCode code="C42998" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TABLET"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Cetirizine Hydrochloride</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <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>
                <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>HYPROMELLOSE, UNSPECIFIED</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="IACT">
                  <ingredientSubstance>
                    <code code="15FIX9V2JP" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>TITANIUM DIOXIDE</name>
                  </ingredientSubstance>
                </ingredient>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="14"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code/>
                    <formCode code="C43168" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BLISTER PACK"/>
                    <asContent>
                      <quantity>
                        <numerator unit="1" value="1"/>
                        <denominator value="1"/>
                      </quantity>
                      <containerPackagedProduct>
                        <code code="25000-160-81" codeSystem="2.16.840.1.113883.6.69"/>
                        <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                      </containerPackagedProduct>
                      <subjectOf>
                        <marketingAct>
                          <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                          <statusCode code="active"/>
                          <effectiveTime>
                            <low value="20250410"/>
                          </effectiveTime>
                        </marketingAct>
                      </subjectOf>
                    </asContent>
                  </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>
                </asContent>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="30"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code/>
                    <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                    <asContent>
                      <quantity>
                        <numerator unit="1" value="1"/>
                        <denominator value="1"/>
                      </quantity>
                      <containerPackagedProduct>
                        <code code="25000-160-03" codeSystem="2.16.840.1.113883.6.69"/>
                        <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                      </containerPackagedProduct>
                      <subjectOf>
                        <marketingAct>
                          <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                          <statusCode code="active"/>
                          <effectiveTime>
                            <low value="20250410"/>
                          </effectiveTime>
                        </marketingAct>
                      </subjectOf>
                    </asContent>
                  </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>
                </asContent>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="1000"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code code="25000-160-14" codeSystem="2.16.840.1.113883.6.69"/>
                    <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                  </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="20250410"/>
                      </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="20250410"/>
                  </effectiveTime>
                </marketingAct>
              </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="CV"/>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLSHAPE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value code="C48345" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OVAL" xsi:type="CV"/>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value unit="mm" value="10" xsi:type="PQ"/>
                </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>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value xsi:type="ST">160</value>
                </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="Section_0">
          <id root="abb14f9e-fd3c-4ede-9230-9c44a6de6001"/>
          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>Active ingredient (in each tablet)</title>
          <text>
            <paragraph>
              <content styleCode="bold">For 5 mg:</content>
            </paragraph>
            <paragraph>Cetirizine HCl USP 5 mg</paragraph>
            <br/>
            <paragraph>
              <content styleCode="bold">For 10 mg:</content>
            </paragraph>
            <paragraph>Cetirizine HCl USP 10 mg</paragraph>
            <br/>
            <paragraph>
              <content styleCode="bold">For 10 mg (Oval Shape):</content>
            </paragraph>
            <paragraph>Cetirizine HCl USP 10 mg</paragraph>
          </text>
          <effectiveTime value="20250605"/>
        </section>
      </component>
      <component>
        <section ID="Section_1">
          <id root="67009302-193b-4b70-98cc-d60f75deec07"/>
          <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="20250605"/>
        </section>
      </component>
      <component>
        <section ID="Section_2">
          <id root="bd3d3e83-e5c0-42fd-8451-e70393ee81c3"/>
          <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>
            <br/>
            <list listType="unordered" styleCode="disc">
              <item>runny nose</item>
              <item>sneezing</item>
              <item>itchy, watery eyes</item>
              <item>itching of the nose or throat</item>
            </list>
          </text>
          <effectiveTime value="20250605"/>
        </section>
      </component>
      <component>
        <section ID="Section_3">
          <id root="94349b93-0a16-4378-a5e6-496b46dd041f"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <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>
            <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>
            <paragraph>
              <content styleCode="bold">Ask a doctor or pharmacist before use if you are </content>taking tranquilizers or sedatives.</paragraph>
            <paragraph>
              <content styleCode="bold">When </content>
              <content styleCode="bold">using </content>
              <content styleCode="bold">this </content>
              <content styleCode="bold">product </content>
            </paragraph>
            <list listType="unordered" styleCode="disc">
              <item>
                <content styleCode="bold"> </content>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>
            <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>
            <paragraph>
              <content styleCode="bold">If pregnant or breast-feeding</content>
            </paragraph>
            <list listType="unordered" styleCode="disc">
              <item>if breast-feeding: not recommended</item>
              <item>if pregnant: ask a health professional before use.</item>
            </list>
            <br/>
            <br/>
          </text>
          <effectiveTime value="20250605"/>
        </section>
      </component>
      <component>
        <section ID="Section_11">
          <id root="e06817e6-5310-4675-a55f-b5a1e3127c86"/>
          <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
          <title>Keep out of reach of children.</title>
          <text>
            <paragraph>In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)</paragraph>
          </text>
          <effectiveTime value="20250605"/>
        </section>
      </component>
      <component>
        <section ID="Section_12">
          <id root="27e211c9-62d4-4040-8371-2898a6d7d1eb"/>
          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>Directions</title>
          <text>
            <paragraph>
              <content styleCode="bold">For 5 mg:</content>
            </paragraph>
            <br/>
            <table border="0" cellpadding="0" cellspacing="0">
              <tbody>
                <tr styleCode="Botrule">
                  <td styleCode="Lrule Rrule" valign="middle">
                    <content styleCode="bold">adults and children 6 years and over</content>
                  </td>
                  <td styleCode="Rrule" valign="middle">1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours</td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Lrule Rrule" valign="middle">
                    <content styleCode="bold">adults 65 years and ove</content>r</td>
                  <td align="left" styleCode="Rrule" valign="middle">1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.</td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Lrule Rrule" valign="middle">
                    <content styleCode="bold">children under 6 years of age</content>
                  </td>
                  <td align="left" styleCode="Rrule" valign="middle">ask a doctor </td>
                </tr>
                <tr>
                  <td styleCode="Lrule Rrule" valign="middle">
                    <content styleCode="bold">consumers with liver or kidney disease</content>
                  </td>
                  <td align="left" styleCode="Rrule" valign="middle">ask a doctor  </td>
                </tr>
              </tbody>
            </table>
            <paragraph>
              <content styleCode="bold"> </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">For 10 mg:</content>
            </paragraph>
            <br/>
            <table border="0" cellpadding="0" cellspacing="0">
              <tbody>
                <tr styleCode="Botrule">
                  <td styleCode="Lrule Rrule" valign="middle">
                    <content styleCode="bold">adults and children 6 years and over</content>
                  </td>
                  <td styleCode="Rrule" valign="middle">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 styleCode="Botrule">
                  <td styleCode="Lrule Rrule" valign="middle">
                    <content styleCode="bold">adults 65 years and over</content>
                  </td>
                  <td align="left" styleCode="Rrule" valign="middle">ask a doctor</td>
                </tr>
                <tr styleCode="Botrule">
                  <td styleCode="Lrule Rrule" valign="middle">
                    <content styleCode="bold">children under 6 years of age</content>
                  </td>
                  <td align="left" styleCode="Rrule" valign="middle">ask a doctor</td>
                </tr>
                <tr>
                  <td styleCode="Lrule Rrule" valign="middle">
                    <content styleCode="bold">consumers with liver or kidney disease</content>
                  </td>
                  <td align="left" styleCode="Rrule" valign="middle">ask a doctor </td>
                </tr>
              </tbody>
            </table>
            <br/>
          </text>
          <effectiveTime value="20250605"/>
        </section>
      </component>
      <component>
        <section ID="Unclassified_Section_1">
          <id root="9c79970f-f615-4579-abf2-469673794a3a"/>
          <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
          <title>Other information</title>
          <text>
            <paragraph>•store between 20° to 25°C (68° to 77°F) <br/> •do not use if foil seal under cap is broken or missing</paragraph>
          </text>
          <effectiveTime value="20250605"/>
        </section>
      </component>
      <component>
        <section ID="Unclassified_Section_2">
          <id root="0750f6cd-4e67-41ba-b7ff-da37a94eca8e"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>Inactive ingredients</title>
          <text>
            <paragraph> corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide</paragraph>
            <br/>
            <paragraph>
              <content styleCode="bold">Questions or comments? </content>Call<content styleCode="bold"> 1-877-376-4271<br/>
              </content>(weekdays 9 AM to 5 PM)</paragraph>
          </text>
          <effectiveTime value="20250605"/>
        </section>
      </component>
      <component>
        <section ID="Section_16">
          <id root="9bb9d549-1cf2-458c-9bfc-e92f50320885"/>
          <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 25000-219-03<br/> Cetirizine Hydrochloride Tablets USP, 5 mg<br/> 30s count bottle label</paragraph>
            <br/>
            <paragraph>
              <renderMultiMedia referencedObject="MM1"/>
            </paragraph>
            <br/>
            <paragraph>NDC 25000-219-03<br/> Cetirizine Hydrochloride Tablets USP, 5 mg<br/> 30s count carton label</paragraph>
            <br/>
            <renderMultiMedia referencedObject="MM2"/>
            <br/>
            <paragraph>     <br/> NDC 25000-219-08 <br/> Cetirizine Hydrochloride Tablets USP, 5 mg<br/> 100s count bottle label</paragraph>
            <br/>
            <paragraph>
              <renderMultiMedia referencedObject="MM3"/>
            </paragraph>
            <br/>
            <paragraph>NDC 25000-219-08 <br/> Cetirizine Hydrochloride Tablets USP, 5 mg<br/> 100s count carton label</paragraph>
            <br/>
            <paragraph>
              <renderMultiMedia referencedObject="MM4"/>
            </paragraph>
            <br/>
            <paragraph>NDC 25000-219-14 <br/> Cetirizine Hydrochloride Tablets USP, 5 mg<br/> 1000s count bottle label  </paragraph>
            <br/>
            <renderMultiMedia referencedObject="MM5"/>
            <br/>
            <br/>
            <paragraph> NDC 25000-220-03 <br/> Cetirizine Hydrochloride Tablets USP, 10 mg</paragraph>
            <paragraph>30s count bottle label</paragraph>
            <paragraph>
              <renderMultiMedia referencedObject="MM6"/>
            </paragraph>
            <paragraph>   </paragraph>
            <br/>
            <paragraph>NDC 25000-220-03 <br/> Cetirizine Hydrochloride Tablets USP, 10 mg</paragraph>
            <paragraph>30s count carton label</paragraph>
            <br/>
            <renderMultiMedia referencedObject="MM7"/>
            <br/>
            <br/>
            <paragraph>NDC 25000-220-08<br/> Cetirizine Hydrochloride Tablets USP, 10 mg<br/> 100s count bottle label</paragraph>
            <paragraph>
              <renderMultiMedia referencedObject="MM8"/>
            </paragraph>
            <paragraph>   </paragraph>
            <br/>
            <paragraph>NDC 25000-220-08<br/> Cetirizine Hydrochloride Tablets USP, 10 mg</paragraph>
            <paragraph>100s count carton label</paragraph>
            <br/>
            <renderMultiMedia referencedObject="MM9"/>
            <br/>
            <br/>
            <paragraph>NDC 25000-220-14<br/> Cetirizine Hydrochloride Tablets USP, 10 mg<br/> 1000s count bottle label</paragraph>
            <br/>
            <renderMultiMedia referencedObject="MM10"/>
            <br/>
            <br/>
            <paragraph>NDC 25000-220-78<br/> Cetirizine Hydrochloride Tablets USP, 10 mg</paragraph>
            <paragraph>7s count carton label</paragraph>
            <br/>
            <renderMultiMedia referencedObject="MM11"/>
            <br/>
            <br/>
            <paragraph>NDC 25000-220-81<br/> Cetirizine Hydrochloride Tablets USP, 10 mg</paragraph>
            <paragraph>14s count carton label</paragraph>
            <br/>
            <renderMultiMedia referencedObject="MM12"/>
            <br/>
            <br/>
            <paragraph>NDC 25000-160-81<br/> Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape)</paragraph>
            <paragraph>14s count carton label</paragraph>
            <br/>
            <renderMultiMedia referencedObject="MM13"/>
            <br/>
            <br/>
            <paragraph>NDC 25000-160-03<br/> Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape)</paragraph>
            <paragraph>30s count carton label</paragraph>
            <br/>
            <renderMultiMedia referencedObject="MM14"/>
            <br/>
            <br/>
            <paragraph>NDC 25000-160-03 (Oval Shape)<br/> Cetirizine Hydrochloride Tablets USP, 10 mg</paragraph>
            <paragraph>30s count bottle label</paragraph>
            <br/>
            <renderMultiMedia referencedObject="MM15"/>
            <br/>
            <br/>
            <paragraph>NDC 25000-160-14<br/> Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape)</paragraph>
            <paragraph>1000s count bottle label</paragraph>
            <br/>
            <paragraph>
              <renderMultiMedia referencedObject="MM16"/>
            </paragraph>
          </text>
          <effectiveTime value="20250731"/>
          <component>
            <observationMedia ID="MM1">
              <text>cetirizine-hcl-5-mg-30ct-bottle</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-5-mg-30ct-bottle.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="MM2">
              <text>cetirizine-hcl-5-mg-30ct-ifc</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-5-mg-30ct-ifc.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="MM3">
              <text>cetirizine-hcl-5-mg-100ct-bottle</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-5-mg-100ct-bottle.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="MM4">
              <text>cetirizine-hcl-5-mg-100ct-ifc</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-5-mg-100ct-ifc.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="MM5">
              <text>cetirizine-hcl-5-mg-1000ct-bottle</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-5-mg-1000ct-bottle.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="MM6">
              <text>10mg-30sbottle</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-10-mg-30s-bottle.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="MM7">
              <text>cetirizine-hcl-10-mg-30s-ifc</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-10-mg-30s-ifc.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="MM8">
              <text>10mg-100sbottle</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-10-mg-100s-bottle.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="MM9">
              <text>cetirizine-hcl-10-mg-100ct-ifc</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-10-mg-100ct-ifc.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="MM10">
              <text>cetirizine-hcl-10-mg-1000s-label</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-10-mg-1000s-label.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="MM11">
              <text>cetirizine-hcl-10-mg-7s-ifc</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-10-mg-7s-ifc.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="MM12">
              <text>cetirizine-hcl-10-mg-14s-ifc</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-10-mg-14s-ifc.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="MM13">
              <text>cetirizine-hcl-10-mg-oval-14s-carton-label</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-10-mg-oval-14s-carton-label.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="MM14">
              <text>cetirizine-hcl-10-mg-oval-30s-carton</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-10-mg-oval-30s-carton.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="MM15">
              <text>cetirizine-hcl-10-mg-oval-30s-label</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-10-mg-oval-30s-label.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="MM16">
              <text>cetirizine-hcl-10-mg-oval-1000s-label</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="cetirizine-hcl-10-mg-oval-1000s-label.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
    </structuredBody>
  </component>
</document>