<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl" type="text/xsl"?>
<document xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="urn:hl7-org:v3" xsi:schemaLocation="urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="2a7fb18d-ef2f-2218-e063-6394a90af89f"/>
   <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
   <title>Maximum Strength
 <br/>
      <br/>
GAS RELIEF
</title>
   <effectiveTime value="20241230"/>
   <setId root="5094ac34-d309-4729-9826-e0b262185b45"/>
   <versionNumber value="5"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="014578892"/>
            <name>RITE AID CORPORATION</name>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="2a7fd775-3f5e-0fa1-e063-6394a90ae204"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20241230"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="11822-1570" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Maximum Strength Gas Relief</name>
                        <formCode code="C42954" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CAPSULE, LIQUID FILLED"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Simethicone</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="9DBA0SBB0L" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>D&amp;C RED NO. 33</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="H3R47K3TBD" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>FD&amp;C BLUE NO. 1</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="2G86QN327L" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>GELATIN</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>GLYCERIN</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="FZ989GH94E" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>POVIDONE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>WATER</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="8KW3E207O2" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SORBITOL SOLUTION</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="ACTIB">
                           <quantity>
                              <numerator unit="mg" value="250"/>
                              <denominator unit="1" value="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="92RU3N3Y1O" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>DIMETHICONE</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="92RU3N3Y1O" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>DIMETHICONE</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="60" unit="1"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="11822-1570-6" 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="20211209"/>
                                 </effectiveTime>
                              </marketingAct>
                           </subjectOf>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="M002" root="2.16.840.1.113883.3.9421"/>
                           <code code="C200263" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OTC Monograph Drug"/>
                           <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="20211209"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <characteristic classCode="OBS">
                           <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C48327" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="purple" 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="C48345" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OVAL" 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="12" 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">250</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="Lbda0d86b-d4c3-45b7-b7af-acdba94d6563">
               <id root="d2bd6bdc-923e-2c23-e053-2a95a90aa695"/>
               <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="20211209"/>
            </section>
         </component>
         <component>
            <section ID="Lbbb98b9a-1e04-4fbf-ad7c-5e3c9314086b">
               <id root="d2bd6bdc-923f-2c23-e053-2a95a90aa695"/>
               <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>Simethicone 250 mg</paragraph>
               </text>
               <effectiveTime value="20211209"/>
            </section>
         </component>
         <component>
            <section ID="L8d65bc73-cf51-4961-924f-f9b0400e4351">
               <id root="d2bd6bdc-9240-2c23-e053-2a95a90aa695"/>
               <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>Anti-gas</paragraph>
               </text>
               <effectiveTime value="20211209"/>
            </section>
         </component>
         <component>
            <section ID="L2e467a29-5a42-4dd5-b306-97da7bb9edf7">
               <id root="d2bd6bdc-9241-2c23-e053-2a95a90aa695"/>
               <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>
                  <paragraph>relives bloating, pressure or fullness commonly referred to as gas</paragraph>
               </text>
               <effectiveTime value="20211209"/>
            </section>
         </component>
         <component>
            <section ID="Lfa4ea2b0-f53e-4651-a297-2dd49c32fee7">
               <id root="d2bd6bdc-9242-2c23-e053-2a95a90aa695"/>
               <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">Stop use and ask a doctor if</content> condition persists
      

 </paragraph>
               </text>
               <effectiveTime value="20211209"/>
            </section>
         </component>
         <component>
            <section ID="L9193b435-ed54-452a-8977-f92cf1146d56">
               <id root="d2bd6bdc-9243-2c23-e053-2a95a90aa695"/>
               <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/>
               </text>
               <effectiveTime value="20211209"/>
            </section>
         </component>
         <component>
            <section ID="L7c17471d-b300-4a51-b3a4-9dc3f93717fc">
               <id root="d2bd6bdc-9244-2c23-e053-2a95a90aa695"/>
               <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>
                  <paragraph>• Swallow one or two softgels after a mea • do not exceed two softgels in 24 hours except under the advice and supervision of a physician</paragraph>
               </text>
               <effectiveTime value="20211209"/>
            </section>
         </component>
         <component>
            <section ID="L3c1f629b-c912-4cba-b161-16cce8886493">
               <id root="d2bd6bdc-9245-2c23-e053-2a95a90aa695"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>
                  <content styleCode="italics">Other Information</content>
               </title>
               <text>
                  <paragraph>• store at room temperature 59-86°F (15-30°C)</paragraph>
               </text>
               <effectiveTime value="20211209"/>
            </section>
         </component>
         <component>
            <section ID="Lef963cb8-ec77-44a3-ae6a-16a8263941f1">
               <id root="d2bd6bdc-9246-2c23-e053-2a95a90aa695"/>
               <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>D&amp;C Red #33, FD&amp;C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol solution, titanium dioxide</paragraph>
               </text>
               <effectiveTime value="20211209"/>
            </section>
         </component>
         <component>
            <section ID="Lc4cddb97-c8be-45ec-a652-fb9be5d41b5c">
               <id root="d2bd6bdc-9247-2c23-e053-2a95a90aa695"/>
               <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>
                     <content styleCode="bold">1-888-333-9792</content>
                  </paragraph>
               </text>
               <effectiveTime value="20211209"/>
            </section>
         </component>
         <component>
            <section ID="Ld22bdd20-5b91-42c5-8476-ef99b1899746">
               <id root="d2bd6bdc-9248-2c23-e053-2a95a90aa695"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Distributed by:</title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Rite Aid</content>
                     <br/>30 Hunter Lane, Camp Hill, Pa 17011
      

 </paragraph>
               </text>
               <effectiveTime value="20211209"/>
            </section>
         </component>
         <component>
            <section ID="La6b76cd3-a77f-41e2-ad5d-381398e20ae1">
               <id root="d2bd6bdc-9249-2c23-e053-2a95a90aa695"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Label</title>
               <text>
                  <paragraph>
                     <renderMultiMedia referencedObject="L7e62cb92-4e38-4f2b-a6b0-ce6534c28e14"/>
                  </paragraph>
               </text>
               <effectiveTime value="20211209"/>
               <component>
                  <observationMedia ID="L7e62cb92-4e38-4f2b-a6b0-ce6534c28e14">
                     <text>Gas Relief Label</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Gas Relief Label.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <section ID="L99d66845-bb10-4e0e-b72e-201f6947b421">
                     <id root="d2bd6bdc-924a-2c23-e053-2a95a90aa695"/>
                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Carton</title>
                     <text>
                        <paragraph>
                           <renderMultiMedia referencedObject="L1096c146-9fdf-4588-8502-740b9dbcd516"/>
                        </paragraph>
                     </text>
                     <effectiveTime value="20211209"/>
                     <component>
                        <observationMedia ID="L1096c146-9fdf-4588-8502-740b9dbcd516">
                           <text>Gas Relief Carton</text>
                           <value mediaType="image/jpeg" xsi:type="ED">
                              <reference value="Gas Relief Carton.jpg"/>
                           </value>
                        </observationMedia>
                     </component>
                  </section>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>