<?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="28db95c4-791e-f01d-e063-6394a90a4e8b"/>
   <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
   <title>REGULAR STRENGTH PAIN RELIEVER</title>
   <effectiveTime value="20241209"/>
   <setId root="4388e547-7d74-4b1d-83b2-674a49ee38a1"/>
   <versionNumber value="4"/>
   <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="28dba2c4-f790-19a1-e063-6394a90a7a78"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20241209"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="68210-4125" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>ACETAMINOPHEN</name>
                        <formCode code="C42998" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TABLET"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>ACETAMINOPHEN</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="O8232NY3SJ" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>STARCH, PREGELATINIZED CORN</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="5856J3G2A2" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>SODIUM STARCH GLYCOLATE TYPE A  POTATO</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="4ELV7Z65AP" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>STEARIC ACID</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="mg" value="325"/>
                              <denominator unit="1" value="1"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="362O9ITL9D" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>ACETAMINOPHEN</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="362O9ITL9D" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>ACETAMINOPHEN</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="100" unit="1"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code code="68210-4125-0" 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="20210406"/>
                                 </effectiveTime>
                              </marketingAct>
                           </subjectOf>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator value="100" 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="68210-4125-1" 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="20210406"/>
                                       </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="20210406"/>
                           </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="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="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">S31</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="Lea3d51d9-f5a8-4a5b-ba99-8d0694c98751">
               <id root="bf512fd3-9f94-3fc4-e053-2995a90af9dc"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="italics">
                        <content styleCode="bold">Drug facts</content>
                     </content>
                  </paragraph>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="Le525c46a-3b92-4058-9f45-dc177dfa620b">
               <id root="bf512fd3-9f95-3fc4-e053-2995a90af9dc"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>
                  <content styleCode="bold">Active ingredient (in each tablet)</content>
               </title>
               <text>
                  <paragraph>Acetaminophen 325 mg</paragraph>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="L602831d6-a138-4452-ac07-f180a4bd60ce">
               <id root="bf512fd3-9f96-3fc4-e053-2995a90af9dc"/>
               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <title>
                  <content styleCode="bold">Purpose</content>
               </title>
               <text>
                  <paragraph>Pain reliever/fever reducer</paragraph>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="L480f0cc8-b1cc-4924-bc93-25e0270bb83d">
               <id root="bf512fd3-9f97-3fc4-e053-2995a90af9dc"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>
                  <content styleCode="bold">Uses</content>
               </title>
               <text>
                  <list listType="unordered">
                     <item>temporarily relieves minor aches and pains due to:</item>
                     <item>the common cold</item>
                     <item>headache</item>
                     <item>backache</item>
                     <item>minor pain of arthritis</item>
                     <item>toothache</item>
                     <item>muscular aches</item>
                     <item>premenstrual and menstrual cramps</item>
                     <item>temporarily reduces fever</item>
                  </list>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="L5f3303d9-33eb-4133-bf77-cd511b7d2bd1">
               <id root="bf512fd3-9f98-3fc4-e053-2995a90af9dc"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <text>
                  <paragraph>Warnings</paragraph>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="L8e50b135-4eb3-4826-ae7d-f2c928fc45c9">
               <id root="bf512fd3-9f99-3fc4-e053-2995a90af9dc"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>
                  <content styleCode="bold">Liver warning</content>
               </title>
               <text>
                  <paragraph>This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if you take</paragraph>
                  <list listType="unordered">
                     <item>more than 4,000 mg of acetaminophen in 24 hours</item>
                     <item>with other drugs containing acetaminophen</item>
                     <item>3 or more alcoholic drugs every day while using this product</item>
                  </list>
                  <paragraph>
                     <content styleCode="bold">Allergy alert:</content> acetaminophen may cause severe skin reactions. Symptoms may include:
      

 
      

 
      

 
      

 </paragraph>
                  <list listType="unordered">
                     <item>Skin reddening</item>
                     <item>Blisters</item>
                     <item>Rash</item>
                  </list>
                  <paragraph>If a skin reaction occurs, stop use and seek medical help right away.</paragraph>
                  <paragraph/>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="L2a055e61-3608-40f5-935a-dac4928c59ed">
               <id root="bf512fd3-9f9a-3fc4-e053-2995a90af9dc"/>
               <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
               <title>
                  <content styleCode="bold">Do not use</content>
               </title>
               <text>
                  <list listType="unordered">
                     <item>with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.</item>
                     <item>if you are allergic to acetaminophen or any of the inactive ingredients in this product.</item>
                  </list>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="L77b5d66f-ecc4-4e0d-a0b6-57e2a807fcbc">
               <id root="bf512fd3-9f9b-3fc4-e053-2995a90af9dc"/>
               <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Ask a doctor before use if you have liver</content> disease
      

 
      

 
      

 
      

 </paragraph>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="L478dc05e-6bb9-4de4-bb60-369283699a7e">
               <id root="bf512fd3-9f9c-3fc4-e053-2995a90af9dc"/>
               <code code="50568-5" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR/PHARMACIST SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Ask a doctor or pharmacist before use if you are</content> taking the blood thinning drug warfarin
      

 
      

 
      

 
      

 </paragraph>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="Lf1beedc6-1609-4df9-99ac-09b66b081bfa">
               <id root="bf512fd3-9f9d-3fc4-e053-2995a90af9dc"/>
               <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
               <title>
                  <content styleCode="bold">Stop use and ask a doctor if</content>
               </title>
               <text>
                  <list listType="unordered">
                     <item>pain gets worse or lasts more than 10 days in adults</item>
                     <item>pain gets worse or lasts more than 5 days in children under 12 years</item>
                     <item>fever gets worse or lasts more than 3 days</item>
                     <item>new symptoms occur</item>
                     <item>redness or swelling is present</item>
                  </list>
                  <paragraph>These could be signs of a serious condition.</paragraph>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="L4f06e4d2-2f80-4aa1-a6b5-988ffbd5fcca">
               <id root="bf512fd3-9f9e-3fc4-e053-2995a90af9dc"/>
               <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">If pregnant or breast-feeding,</content> ask a health professional before use.
      

 
      

 
      

 
      

 </paragraph>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="La190d360-771a-4b8a-b321-ca5ee293c40d">
               <id root="bf512fd3-9f9f-3fc4-e053-2995a90af9dc"/>
               <code code="50565-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - KEEP OUT OF REACH OF CHILDREN SECTION"/>
               <text>
                  <paragraph>
                     <content styleCode="bold">Keep out of reach of children.</content>
                  </paragraph>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="Laf311bde-e9fe-4289-ad26-bfd75a567cc9">
               <id root="bf512fd3-9fa0-3fc4-e053-2995a90af9dc"/>
               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>
                  <content styleCode="bold">Overdose warning</content>
               </title>
               <text>
                  <paragraph>In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.</paragraph>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="Lf7fa9a19-8c97-4342-9560-4aeb5b4ba003">
               <id root="bf512fd3-9fa1-3fc4-e053-2995a90af9dc"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>
                  <content styleCode="bold">Directions</content>
               </title>
               <text>
                  <paragraph>do not take more than directed 
       
 
  
       
 
  
       
 
  
       
 
  <content styleCode="bold">(see overdose warning)</content>
                  </paragraph>
                  <table width="100%">
                     <caption/>
                     <tbody>
                        <tr>
                           <td> adults and children 12 years and over</td>
                           <td>
                              <list listType="unordered">
                                 <item> take 2 tablets every 4 to 6 hours while symptoms last</item>
                                 <item>do not take more than 10 tablets in 24 hours, unless directed by a doctor</item>
                                 <item>do not use for more than 10 days unless directed by a doctor</item>
                              </list>
                           </td>
                        </tr>
                        <tr>
                           <td> children 6 years to under 12 years</td>
                           <td>
                              <list listType="unordered">
                                 <item> take 1 tablet every 4 to 6 hours while symptoms last</item>
                                 <item>do not take more than 5 tablets in 24 hours</item>
                                 <item>do not use for more than 5 days unless directed by a doctor</item>
                              </list>
                           </td>
                        </tr>
                        <tr>
                           <td> children under 6 years   </td>
                           <td> ask a doctor</td>
                        </tr>
                     </tbody>
                  </table>
                  <paragraph/>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="L3e02b048-dcaa-4ef9-8de8-3d7dca10570b">
               <id root="bf512fd3-9fa2-3fc4-e053-2995a90af9dc"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>
                  <content styleCode="bold">Other information</content>
               </title>
               <text>
                  <list listType="unordered">
                     <item>store between 20-25°C (68-77°F)</item>
                     <item>do not use if carton is opened or neck wrap or foil inner seal imprinted with "SAFETY SEAL" is broken or missing</item>
                  </list>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="Lf47edd8d-a9d5-426b-b03b-769d4bf8719b">
               <id root="bf512fd3-9fa3-3fc4-e053-2995a90af9dc"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>
                  <content styleCode="bold">Inactive ingredients</content>
               </title>
               <text>
                  <paragraph>povidone, pregelatinized starch, sodium starch glycolate, stearic acid</paragraph>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="L8633b847-902a-4b62-9516-d67e44da92d2">
               <id root="bf512fd3-9fa4-3fc4-e053-2995a90af9dc"/>
               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <title>
                  <content styleCode="bold">Questions or comments?</content>
               </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">1-888-333-9792</content>
                  </paragraph>
               </text>
               <effectiveTime value="20210406"/>
            </section>
         </component>
         <component>
            <section ID="L33fa40db-5493-45f4-828b-33199d2e7d35">
               <id root="bf512fd3-9fa5-3fc4-e053-2995a90af9dc"/>
               <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>SPRIIT 360</paragraph>
                  <paragraph>REGULAR STRENGTH </paragraph>
                  <paragraph>PAIN RELIEVER</paragraph>
                  <paragraph>ACETAMINOPHEN 325 mg</paragraph>
                  <paragraph>PAIN RELIEVER / FEVER REDUCER</paragraph>
                  <paragraph>100 TABLETS</paragraph>
                  <paragraph>
                     <renderMultiMedia referencedObject="Ldb906d22-aaed-4a17-b11f-f2197f563c41"/>
                  </paragraph>
               </text>
               <effectiveTime value="20210406"/>
               <component>
                  <observationMedia ID="Ldb906d22-aaed-4a17-b11f-f2197f563c41">
                     <text>image description</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="RS PAIN RELIEVER.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>