<?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="e6496ffd-fe5a-8b04-e053-2a95a90a8ced"/>
  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <title>Zantac 360, 2 tablet per blister, 6 blisters</title>
  <effectiveTime value="20220815"/>
  <setId root="fd61a2d6-5c8a-4e7a-8b19-37406b90f778"/>
  <versionNumber value="1"/>
  <author>
    <time/>
    <assignedEntity>
      <representedOrganization>
        <id extension="805257581" root="1.3.6.1.4.1.519.1"/>
        <name>JC World Bell Wholesale Co., Inc.</name>
        <assignedEntity>
          <assignedOrganization/>
        </assignedEntity>
      </representedOrganization>
    </assignedEntity>
  </author>
  <component>
    <structuredBody>
      <component>
        <section>
          <id root="e64a266e-8318-c919-e053-2a95a90a454f"/>
          <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
          <effectiveTime value="20220815"/>
          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="50269-156" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Zantac 360 2 per blister 6 blisters</name>
                <formCode code="C42931" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TABLET, FILM COATED"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>FAMOTIDINE</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <asEquivalentEntity classCode="EQUIV">
                  <code code="C64637" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                  <definingMaterialKind>
                    <code code="41167-0361" codeSystem="2.16.840.1.113883.6.69"/>
                  </definingMaterialKind>
                </asEquivalentEntity>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="R12CBM0EIZ" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>CARNAUBA WAX</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="9XZ8H6N6OH" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>HYDROXYPROPYL CELLULOSE, UNSPECIFIED</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="70097M6I30" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>MAGNESIUM STEARATE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="OP1R32D61U" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>MICROCRYSTALLINE CELLULOSE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="1K09F3G675" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>FERRIC OXIDE RED</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="H8AV0SQX4D" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SODIUM STARCH GLYCOLATE TYPE A</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="7SEV7J4R1U" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>TALC</name>
                  </ingredientSubstance>
                </ingredient>
                <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="EX438O2MRT" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>FERRIC OXIDE YELLOW</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="mg" value="20"/>
                    <denominator unit="1" value="1"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="5QZO15J2Z8" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>FAMOTIDINE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="5QZO15J2Z8" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>FAMOTIDINE</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <asContent>
                  <quantity>
                    <numerator unit="1" value="2"/>
                    <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="6"/>
                        <denominator value="1"/>
                      </quantity>
                      <containerPackagedProduct>
                        <code code="50269-156-01" codeSystem="2.16.840.1.113883.6.69"/>
                        <formCode code="C43178" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOX"/>
                      </containerPackagedProduct>
                      <subjectOf>
                        <marketingAct>
                          <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                          <statusCode code="active"/>
                          <effectiveTime>
                            <low value="20211001"/>
                          </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="ANDA206531" 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="20211001"/>
                  </effectiveTime>
                </marketingAct>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value code="C48330" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="yellow" xsi:type="CE">
                    <originalText/>
                  </value>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLSHAPE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value code="C48348" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ROUND" xsi:type="CE">
                    <originalText/>
                  </value>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value unit="mm" value="5" xsi:type="PQ"/>
                </characteristic>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
                  <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/>
                  <value xsi:type="ST">CC;59</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="Ldbac7d4d-9a1e-4c24-a2f4-7001de2cb23e">
          <id root="e6496ffd-fe5b-8b04-e053-2a95a90a8ced"/>
          <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
          <title>
            <content styleCode="italics">Drug Facts</content>
          </title>
          <text>
            <paragraph/>
          </text>
          <effectiveTime value="20220810"/>
        </section>
      </component>
      <component>
        <section ID="Laa17fdc0-bcba-437f-94a6-17bf98b645ad">
          <id root="e6496ffd-fe5c-8b04-e053-2a95a90a8ced"/>
          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>
            <content styleCode="italics">Active ingredient (in each tablet)</content>
          </title>
          <text>
            <paragraph>Famotidine USP 20mg</paragraph>
          </text>
          <effectiveTime value="20220810"/>
          <component>
            <section ID="L6b213ac3-74f8-43db-9651-3d912903eb65">
              <id root="e6496ffd-fe5d-8b04-e053-2a95a90a8ced"/>
              <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
              <title>
                <content styleCode="italics">Purpose</content>
              </title>
              <text>
                <paragraph>Acid reducer</paragraph>
              </text>
              <effectiveTime value="20220810"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section ID="L69f43d59-d0b7-4349-91c8-d996898eadc8">
          <id root="e6496ffd-fe5e-8b04-e053-2a95a90a8ced"/>
          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>
            <content styleCode="italics">Uses</content>
          </title>
          <text>
            <list listType="unordered">
              <item>relieves heartburn associated with acid indigestion and sour stomach</item>
              <item>prevent heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages</item>
            </list>
          </text>
          <effectiveTime value="20220810"/>
        </section>
      </component>
      <component>
        <section ID="Ld91cfa3a-616b-4f06-bc33-7b527d83bcb7">
          <id root="e6496ffd-fe5f-8b04-e053-2a95a90a8ced"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>
            <content styleCode="italics">Warnings</content>
          </title>
          <text>
            <paragraph>
              <content styleCode="bold">Allergy alert:</content> Do not use if you are allergic to famotidine or other acid reducers
      

 </paragraph>
          </text>
          <effectiveTime value="20220810"/>
          <component>
            <section ID="Lbd3495ac-e7f5-41b5-88b2-45458e776c0d">
              <id root="e6496ffd-fe60-8b04-e053-2a95a90a8ced"/>
              <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">
                  <item>if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.</item>
                  <item>with other acid reducers</item>
                </list>
              </text>
              <effectiveTime value="20220810"/>
            </section>
          </component>
          <component>
            <section ID="L15bab6b5-edc1-4cf3-a6e4-a6ced6b10d42">
              <id root="e6496ffd-fe61-8b04-e053-2a95a90a8ced"/>
              <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">
                  <item>had heartburn over 3 months. This may be a sign of a more serious condition.</item>
                  <item>heartburn with</item>
                </list>
                <paragraph>
                  <content styleCode="bold">lightheadedness, sweating, or dizziness</content>
                </paragraph>
                <list listType="unordered">
                  <item>chest pain or shoulder pain with shortness or breath; sweating, pain spreading to arms, neck or shoulders; or lightheadedness</item>
                  <item>frequent 
          
  
   <content styleCode="bold">chest pain</content> frequent wheezing, particularly with heartburn
         
 
  </item>
                  <item>unexplained weight loss </item>
                  <item>nausea or vomiting </item>
                  <item>stomach pain </item>
                  <item>kidney disease</item>
                </list>
              </text>
              <effectiveTime value="20220810"/>
            </section>
          </component>
          <component>
            <section ID="Lfa17a57a-1404-4297-aa77-faa1fa7aeb3d">
              <id root="e6496ffd-fe62-8b04-e053-2a95a90a8ced"/>
              <code code="50568-5" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR/PHARMACIST SECTION"/>
              <title>Ask a doctor or pharmacist before use if you are</title>
              <text>
                <paragraph>taking a prescription drug. Acid reducers may interact with certain prescription drugs.</paragraph>
              </text>
              <effectiveTime value="20220810"/>
            </section>
          </component>
          <component>
            <section ID="L6f88d843-5d60-4593-9898-5687379d8824">
              <id root="e6496ffd-fe63-8b04-e053-2a95a90a8ced"/>
              <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">
                  <item>your heartburn continues or worsens</item>
                  <item>you need to take this product for more than 14 days</item>
                </list>
              </text>
              <effectiveTime value="20220810"/>
            </section>
          </component>
          <component>
            <section ID="Ld754ffe7-8fd8-4d2e-8e41-2f6d3155cc16">
              <id root="e6496ffd-fe64-8b04-e053-2a95a90a8ced"/>
              <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
              <title>If pregnant or breast-feeding,</title>
              <text>
                <paragraph>ask a health professional before use.</paragraph>
              </text>
              <effectiveTime value="20220810"/>
            </section>
          </component>
          <component>
            <section ID="L398cc333-4a75-45e3-a088-3a277613b0a7">
              <id root="e6496ffd-fe65-8b04-e053-2a95a90a8ced"/>
              <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 (1-800-222-1222) right away.</paragraph>
              </text>
              <effectiveTime value="20220810"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section ID="L37f02075-155b-48d7-8ae0-616fd1a711b7">
          <id root="e6496ffd-fe66-8b04-e053-2a95a90a8ced"/>
          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>
            <content styleCode="italics">Directions</content>
          </title>
          <text>
            <list listType="unordered">
              <item>adults and children 12 years and over:</item>
              <item>to 
        
  
   <content styleCode="bold">relieve</content> symptoms, swallow 1 tablet with a glass or water. Do not chew.
       
 
  </item>
              <item>to 
        
  
   <content styleCode="bold">prevent</content> symptoms, swallow 1 tablet with a glass of water at any time from 
        
  
   <content styleCode="bold">10 to 60 minutes before</content> eating food or drinking beverages that cause heartburn
       
 
  </item>
              <item>do not use more than 2 tablets in 24 hours</item>
              <item>children under 12 years: ask a doctor</item>
            </list>
          </text>
          <effectiveTime value="20220810"/>
        </section>
      </component>
      <component>
        <section ID="L67c77987-1efe-4b44-a7b2-7bf575248019">
          <id root="e6496ffd-fe67-8b04-e053-2a95a90a8ced"/>
          <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
          <title>
            <content styleCode="italics">Other information</content>
          </title>
          <text>
            <list listType="unordered">
              <item>read the directions and warnings before use</item>
              <item>keep the carton. It contains important information.</item>
              <item>store at 20°25°C (68°F-77°F)</item>
              <item>protect from moisture</item>
            </list>
          </text>
          <effectiveTime value="20220810"/>
        </section>
      </component>
      <component>
        <section ID="Lf3122a69-3d5e-400a-848c-c2db8a0e38de">
          <id root="e6496ffd-fe68-8b04-e053-2a95a90a8ced"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>
            <content styleCode="italics">Inactive ingredients</content>
          </title>
          <text>
            <paragraph>carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide</paragraph>
          </text>
          <effectiveTime value="20220810"/>
        </section>
      </component>
      <component>
        <section ID="L1dd28315-b266-4377-961b-f4ecdcea28b7">
          <id root="e6496ffd-fe69-8b04-e053-2a95a90a8ced"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>
            <content styleCode="italics">Questions or comments?</content>
          </title>
          <text>
            <paragraph>call 
       
 
  <content styleCode="bold">1-800-633-1610</content> or visit 
       
 
  <content styleCode="bold">www.zantacotc.com</content>
            </paragraph>
          </text>
          <effectiveTime value="20220810"/>
        </section>
      </component>
      <component>
        <section ID="Lb13a5e64-d5b0-4a08-8adc-63ace0e3166c">
          <id root="e6496ffd-fe6a-8b04-e053-2a95a90a8ced"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>Package Labeling:</title>
          <text>
            <paragraph>
              <renderMultiMedia referencedObject="L512552db-916f-4745-93a7-421b06d0a568"/>
              <renderMultiMedia referencedObject="L8a982b22-a910-44c3-9efe-d8876ec18264"/>
            </paragraph>
          </text>
          <effectiveTime value="20220810"/>
          <component>
            <observationMedia ID="L512552db-916f-4745-93a7-421b06d0a568">
              <text>Outer Package2</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="Outer Package2.jpg"/>
              </value>
            </observationMedia>
          </component>
          <component>
            <observationMedia ID="L8a982b22-a910-44c3-9efe-d8876ec18264">
              <text>Inner Package2</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="Inner Package2.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
      </component>
    </structuredBody>
  </component>
</document>