<?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="292de224-4f72-28dd-e063-6394a90a08b6"/>
   <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
   <title>ASPIRIN 81MG ADULT LOW DOSE</title>
   <effectiveTime value="20241213"/>
   <setId root="199f0043-17f6-4620-9658-b4b07fb50be7"/>
   <versionNumber value="2"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id root="1.3.6.1.4.1.519.1" extension="179621011"/>
            <name>Spirit Pharmaceuticals LLC</name>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="292de516-26a7-2982-e063-6394a90a2232"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20241213"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="68210-5029" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Low Dose Aspirin</name>
                        <formCode code="C42905" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TABLET, DELAYED RELEASE"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Aspirin</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="1CS02G8656" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>METHACRYLIC ACID</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="ETJ7Z6XBU4" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SILICON DIOXIDE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="M28OL1HH48" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CROSCARMELLOSE SODIUM</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="35SW5USQ3G" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>D&amp;C YELLOW NO. 10</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="J2B2A4N98G" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>LACTOSE, UNSPECIFIED FORM</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="6OZP39ZG8H" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>POLYSORBATE 80</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="55X04QC32I" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SODIUM HYDROXIDE</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="8Z96QXD6UM" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>TRIETHYL CITRATE</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="81"/>
                              <denominator unit="1" value="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="R16CO5Y76E" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>ASPIRIN</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="R16CO5Y76E" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>ASPIRIN</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="40" unit="1"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                              <asContent>
                                 <quantity>
                                    <numerator value="1" unit="1"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="68210-5029-4" 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="20231214"/>
                                       </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="M013" 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="20231214"/>
                           </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="8" 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">81</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="L9a496c7f-7956-4255-b3fb-68923db62871">
               <id root="0c7c4492-ef52-0614-e063-6294a90a78ba"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Drug Facts</title>
               <text/>
               <effectiveTime value="20231214"/>
            </section>
         </component>
         <component>
            <section ID="L5fac098d-0720-4bbd-bb1b-0a694c660966">
               <id root="0c7c4492-ef53-0614-e063-6294a90a78ba"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>Active Ingredient (in each tablet) 
 <br/>
                  <br/>  Aspirin 81 mg (NSAID)nonsterodial anti-inflammatory drug
</title>
               <text>
                  <paragraph/>
               </text>
               <effectiveTime value="20231214"/>
            </section>
         </component>
         <component>
            <section ID="L705597e8-aef0-47ce-a752-92f6d2a73a03">
               <id root="0c7c4492-ef54-0614-e063-6294a90a78ba"/>
               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <title>Purpose 
 <br/>  Pain reliever
</title>
               <text>
                  <paragraph/>
               </text>
               <effectiveTime value="20231214"/>
            </section>
         </component>
         <component>
            <section ID="L4ede2504-7ee1-417b-a5c9-936f263d3aa9">
               <id root="0c7c4492-ef55-0614-e063-6294a90a78ba"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>Uses 
 <br/>
               </title>
               <text/>
               <effectiveTime value="20231214"/>
            </section>
         </component>
         <component>
            <section ID="L5b67e1b9-67b2-4f6e-a791-e76a7ad269ef">
               <id root="0c7c4492-ef56-0614-e063-6294a90a78ba"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>Warnings 
 <br/>
                  <content styleCode="bold">Reye's syndrome</content>: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reyes syndrome, a rare but serious illness.

 <content styleCode="bold">Allergy alert</content>: Aspirin may cause a severe allergic reaction which may include: hives, facial swelling, asthma(wheezing), shock

 <content styleCode="bold">Stomach bleeding warning</content>: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or olderHave had stomach ulcers or bleeding problemsTake a blood thinning (Anticogulant) or steroid drugTake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day using this product
</title>
               <text/>
               <effectiveTime value="20231214"/>
            </section>
         </component>
         <component>
            <section ID="L3e77b5bf-176f-4fae-b923-9b6ecb66ecb0">
               <id root="0c7c4492-ef57-0614-e063-6294a90a78ba"/>
               <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
               <title>Do not Use 
 <br/>
                  <br/>  if you are allergic to aspirin or any other pain reliever/fever reducerif you have ever had an allergic reaction to this product or any of its ingredients
</title>
               <text/>
               <effectiveTime value="20231214"/>
            </section>
         </component>
         <component>
            <section ID="L63a169ab-4b0f-4152-8904-8d4523ae3bb0">
               <id root="0c7c4492-ef58-0614-e063-6294a90a78ba"/>
               <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
               <title>Ask a doctor before use if stomach bleeding warning applies to you 
 <br/>  you ahistory of stomach problems such as heart burnyou have blood pressure, heart disease, liver cirrhosis, or kidney disease 
 <br/>  you are taking a diuretic, you have asthama
</title>
               <text/>
               <effectiveTime value="20231214"/>
            </section>
         </component>
         <component>
            <section ID="L6e188574-5a9b-443a-9e28-e6b38606bf16">
               <id root="0c7c4492-ef59-0614-e063-6294a90a78ba"/>
               <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 Ask a doctor or pharmacist before use if you are taking a prescription drug for:Gout, Diabetes, Arthritis</title>
               <text>
                  <paragraph/>
               </text>
               <effectiveTime value="20231214"/>
            </section>
         </component>
         <component>
            <section ID="L10a37dd0-4557-4909-8a79-27fb31c4193f">
               <id root="0c7c4492-ef5a-0614-e063-6294a90a78ba"/>
               <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 an allergic reaction occurs. Seek medical help right away.You experience any of the following signs of stomach bleeding: feel faint, vomt blood, have bloody or black stools, have stomach pain that does not get better, pain get worse or lasts more than 10 days, fever gets worse or lasts more than 3 daysredness or swelling is present, new symptons occurringing in the ears or a loss of hearing occurs.</title>
               <text/>
               <effectiveTime value="20231214"/>
            </section>
         </component>
         <component>
            <section ID="Lc1c0e101-4eb8-4bd2-b9d3-b5f48d1c2c78">
               <id root="0c7c4492-ef5b-0614-e063-6294a90a78ba"/>
               <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 ask ahealth professional before use. it is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it my cause problems in the unborn child or complications during delivery.</title>
               <text/>
               <effectiveTime value="20231214"/>
            </section>
         </component>
         <component>
            <section ID="L694e4bf8-1f83-4058-a4d9-f386f1f3fa8f">
               <id root="0c7c4492-ef5c-0614-e063-6294a90a78ba"/>
               <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 In case of overdose, get medical help or contact poison control center right away.</title>
               <text>
                  <paragraph/>
               </text>
               <effectiveTime value="20231214"/>
            </section>
         </component>
         <component>
            <section ID="L4dce89a2-88c0-4358-afa6-c3d6630ccc71">
               <id root="0c7c4492-ef5d-0614-e063-6294a90a78ba"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Directions</title>
               <text>
                  <paragraph>drink a full glass of water with each dose</paragraph>
                  <paragraph>adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor</paragraph>
               </text>
               <effectiveTime value="20231214"/>
            </section>
         </component>
         <component>
            <section ID="Lf0516bba-4461-4c75-8894-49de9b581a42">
               <id root="0c7c4492-ef5e-0614-e063-6294a90a78ba"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>Other information</title>
               <text>
                  <paragraph>Store at room temparature. Avoid excessive heat above 40°C (104 °F) </paragraph>
               </text>
               <effectiveTime value="20231214"/>
            </section>
         </component>
         <component>
            <section ID="La0407817-9e51-46fb-8cbe-9aba01c7aba0">
               <id root="0c7c4492-ef5f-0614-e063-6294a90a78ba"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>Inactive ingredients</title>
               <text>
                  <paragraph>acrycoat, colloidal silicon dioxide, croscarmellose sodium, D&amp;C yellow # 10, Lactose, microcrystalline cellulose, polysorbate 80,</paragraph>
                  <paragraph>sodium hydroxide, talc, titanium dioxide, triethyl citrate, yellow oxide of iron </paragraph>
               </text>
               <effectiveTime value="20231214"/>
            </section>
         </component>
         <component>
            <section ID="L4ac13812-e46b-4b8f-9252-e179b705bcd2">
               <id root="0c7c4492-ef60-0614-e063-6294a90a78ba"/>
               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <title>Questions or Comments</title>
               <text>
                  <paragraph>1-888-333-9792</paragraph>
               </text>
               <effectiveTime value="20231214"/>
            </section>
         </component>
         <component>
            <section ID="L6508d9f4-f5fc-4c39-9692-c613e1822a98">
               <id root="0c7c4492-ef61-0614-e063-6294a90a78ba"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Principal Display</title>
               <text>
                  <paragraph/>
                  <renderMultiMedia referencedObject="L88e697ce-fed0-4906-9f61-7f2717280f38"/>
               </text>
               <effectiveTime value="20231214"/>
               <component>
                  <observationMedia ID="L88e697ce-fed0-4906-9f61-7f2717280f38">
                     <text>Carton</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="Carton.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>