<?xml version="1.0" encoding="UTF-8"?><?xml-stylesheet href="http://www.accessdata.fda.gov/spl/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 http://www.accessdata.fda.gov/spl/schema/spl.xsd">
   <id root="5bfd9841-c781-43be-b823-d334893ae6ed"/>
   <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
   <title>Kroger Co. Acetaminophen Drug Facts</title>
   <effectiveTime value="20150824"/>
   <setId root="5bfd9841-c781-43be-b823-d334893ae6ed"/>
   <versionNumber value="1"/>
   <author>
      <time/>
      <assignedEntity>
         <representedOrganization>
            <id extension="006999528" root="1.3.6.1.4.1.519.1"/>
            <name>Kroger Company</name>
         </representedOrganization>
      </assignedEntity>
   </author>
   <component>
      <structuredBody>
         <component>
            <section>
               <id root="3f68cef5-318a-4c98-9f8a-49ca8c3b30db"/>
               <code code="48780-1" codeSystem="2.16.840.1.113883.6.1" displayName="SPL product data elements section"/>
               <effectiveTime value="20150824"/>
               <subject>
                  <manufacturedProduct>
                     <manufacturedProduct>
                        <code code="30142-507" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Acetaminophen</name>
                        <formCode code="C42895" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CAPSULE, COATED"/>
                        <asEntityWithGeneric>
                           <genericMedicine>
                              <name>Acetaminophen</name>
                           </genericMedicine>
                        </asEntityWithGeneric>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator unit="mg" value="500"/>
                              <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>
                        <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="68401960MK" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>CROSPOVIDONE</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="3NXW29V3WO" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>HYPROMELLOSES</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="3WJQ0SDW1A" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>POLYETHYLENE GLYCOLS</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="FZ989GH94E" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>POVIDONES</name>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="IACT">
                           <ingredientSubstance>
                              <code code="4ELV7Z65AP" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>STEARIC ACID</name>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator unit="1" value="24"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                              <asContent>
                                 <quantity>
                                    <numerator unit="1" value="1"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="30142-507-62" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                           <subjectOf>
                              <characteristic classCode="OBS">
                                 <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="CE"/>
                              </characteristic>
                           </subjectOf>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator unit="1" value="100"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                              <asContent>
                                 <quantity>
                                    <numerator unit="1" value="1"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="30142-507-78" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                           <subjectOf>
                              <characteristic classCode="OBS">
                                 <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="CE"/>
                              </characteristic>
                           </subjectOf>
                        </asContent>
                        <asContent>
                           <quantity>
                              <numerator unit="1" value="225"/>
                              <denominator value="1"/>
                           </quantity>
                           <containerPackagedProduct>
                              <code/>
                              <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
                              <asContent>
                                 <quantity>
                                    <numerator unit="1" value="1"/>
                                    <denominator value="1"/>
                                 </quantity>
                                 <containerPackagedProduct>
                                    <code code="30142-507-83" codeSystem="2.16.840.1.113883.6.69"/>
                                    <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
                                 </containerPackagedProduct>
                              </asContent>
                           </containerPackagedProduct>
                           <subjectOf>
                              <characteristic classCode="OBS">
                                 <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="CE"/>
                              </characteristic>
                           </subjectOf>
                        </asContent>
                     </manufacturedProduct>
                     <subjectOf>
                        <approval>
                           <id extension="part343" root="2.16.840.1.113883.3.149"/>
                           <code code="C73604" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="OTC monograph not final"/>
                           <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="20150818"/>
                           </effectiveTime>
                        </marketingAct>
                     </subjectOf>
                     <subjectOf>
                        <characteristic classCode="OBS">
                           <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C48326" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="RED" xsi:type="CE"/>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic classCode="OBS">
                           <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value unit="mm" value="18" xsi:type="PQ"/>
                        </characteristic>
                     </subjectOf>
                     <subjectOf>
                        <characteristic classCode="OBS">
                           <code code="SPLSHAPE" codeSystem="2.16.840.1.113883.1.11.19255"/>
                           <value code="C48336" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CAPSULE" xsi:type="CE"/>
                        </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">3S0</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="ID_fe4350a9-2217-4321-9f91-e1fef09e1f80">
               <id root="fe4350a9-2217-4321-9f91-e1fef09e1f80"/>
               <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
               <title>Active ingredient (in each caplet)</title>
               <text>
                  <paragraph>Acetaminophen 500 mg</paragraph>
               </text>
               <effectiveTime value="20150824"/>
            </section>
         </component>
         <component>
            <section ID="ID_614a3ae3-3529-4b4a-93bb-c49f0fd89a12">
               <id root="614a3ae3-3529-4b4a-93bb-c49f0fd89a12"/>
               <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
               <title>Purpose</title>
               <text>
                  <paragraph>Pain reliever/fever reducer</paragraph>
               </text>
               <effectiveTime value="20150824"/>
            </section>
         </component>
         <component>
            <section ID="ID_4e0dad31-2fe6-40ba-9cc8-97efd6439130">
               <id root="4e0dad31-2fe6-40ba-9cc8-97efd6439130"/>
               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>Uses</title>
               <text>
                  <list listType="unordered">
                     <item>
                        <caption>•</caption>temporarily relieves minor aches and pains due to:</item>
                     <item>
                        <caption>•</caption>the common cold</item>
                     <item>
                        <caption>•</caption>headache</item>
                     <item>
                        <caption>•</caption>backache</item>
                     <item>
                        <caption>•</caption>minor pain of arthritis</item>
                     <item>
                        <caption>•</caption>toothache</item>
                     <item>
                        <caption>•</caption>muscular aches</item>
                     <item>
                        <caption>•</caption>premenstrual and menstrual cramps</item>
                     <item>
                        <caption>•</caption>temporarily reduces fever</item>
                  </list>
               </text>
               <effectiveTime value="20150824"/>
            </section>
         </component>
         <component>
            <section ID="ID_3da4fae6-e519-4b82-b0c6-4ca2c38ab6e0">
               <id root="3da4fae6-e519-4b82-b0c6-4ca2c38ab6e0"/>
               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>Warnings</title>
               <text>
                  <paragraph>Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take</paragraph>
                  <list listType="unordered">
                     <item>
                        <caption>•</caption>more than 4,000 mg of acetaminophen in 24 hours</item>
                     <item>
                        <caption>•</caption>with other drugs containing acetaminophen</item>
                     <item>
                        <caption>•</caption>3 or more alcoholic drinks every day while using this product</item>
                  </list>
                  <paragraph>Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:</paragraph>
                  <list listType="unordered">
                     <item>
                        <caption>•</caption>skin reddening</item>
                     <item>
                        <caption>•</caption>blisters</item>
                     <item>
                        <caption>•</caption>rash</item>
                  </list>
                  <paragraph>If a skin reaction occurs, stop use and seek medical help right away.</paragraph>
               </text>
               <effectiveTime value="20150824"/>
            </section>
         </component>
         <component>
            <section ID="ID_5e4b634a-ffab-4966-9a37-8408545ed3eb">
               <id root="5e4b634a-ffab-4966-9a37-8408545ed3eb"/>
               <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>
                        <caption>•</caption>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>
                        <caption>•</caption>if you have ever had an allergic reaction to this product or any of its ingredients</item>
                  </list>
               </text>
               <effectiveTime value="20150824"/>
            </section>
         </component>
         <component>
            <section ID="ID_dcc2fb07-ebbe-426d-b9ad-4eac1a2c4187">
               <id root="dcc2fb07-ebbe-426d-b9ad-4eac1a2c4187"/>
               <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>
                  <paragraph>liver disease</paragraph>
               </text>
               <effectiveTime value="20150824"/>
            </section>
         </component>
         <component>
            <section ID="ID_3c86955c-90a6-41cf-98c8-3cbf69674ed6">
               <id root="3c86955c-90a6-41cf-98c8-3cbf69674ed6"/>
               <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 the blood thinning drug warfarin</paragraph>
               </text>
               <effectiveTime value="20150824"/>
            </section>
         </component>
         <component>
            <section ID="ID_3e0afa20-b159-445e-80e4-6ec3d01355d5">
               <id root="3e0afa20-b159-445e-80e4-6ec3d01355d5"/>
               <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>
                        <caption>•</caption>pain gets worse or lasts more than 10 days</item>
                     <item>
                        <caption>•</caption>fever gets worse or lasts more than 3 days</item>
                     <item>
                        <caption>•</caption>new symptoms occur</item>
                     <item>
                        <caption>•</caption>redness or swelling is present</item>
                  </list>
                  <paragraph>These could be signs of a serious condition.</paragraph>
               </text>
               <effectiveTime value="20150824"/>
            </section>
         </component>
         <component>
            <section ID="ID_c59256c1-fbcd-4c0d-8b09-894d24ab6347">
               <id root="c59256c1-fbcd-4c0d-8b09-894d24ab6347"/>
               <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="20150824"/>
            </section>
         </component>
         <component>
            <section ID="ID_0fecc8de-da95-400b-b562-753bf791d921">
               <id root="0fecc8de-da95-400b-b562-753bf791d921"/>
               <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>Overdose warning: 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="20150824"/>
            </section>
         </component>
         <component>
            <section ID="ID_7c78ad70-f02e-485f-b082-f2424efcfeea">
               <id root="7c78ad70-f02e-485f-b082-f2424efcfeea"/>
               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Directions</title>
               <text>
                  <list listType="unordered">
                     <item>
                        <caption>•</caption>do not take more than directed (see overdose warning)</item>
                  </list>
                  <table>
                     <col width="20%"/>
                     <col width="80%"/>
                     <tbody>
                        <tr>
                           <td styleCode="Rrule Botrule Lrule Toprule " valign="top">
                              <paragraph>adults and children 12 years and over</paragraph>
                           </td>
                           <td styleCode="Rrule Botrule Lrule Toprule " valign="top">
                              <list listType="unordered">
                                 <item>
                                    <caption>•</caption>take 2 caplets every 6 hours while symptoms last</item>
                                 <item>
                                    <caption>•</caption>do not take more than 6 caplets in 24 hours, unless directed by a doctor</item>
                                 <item>
                                    <caption>•</caption>do not use for more than 10 days unless directed by a doctor</item>
                              </list>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Rrule Botrule Lrule Toprule " valign="top">
                              <paragraph>children under</paragraph>
                              <paragraph>12 years</paragraph>
                           </td>
                           <td styleCode="Rrule Botrule Lrule Toprule " valign="top">
                              <paragraph>ask a doctor</paragraph>
                           </td>
                        </tr>
                     </tbody>
                  </table>
               </text>
               <effectiveTime value="20150824"/>
            </section>
         </component>
         <component>
            <section ID="ID_24c96c4f-52c7-4bd8-a425-922a9acb3d47">
               <id root="24c96c4f-52c7-4bd8-a425-922a9acb3d47"/>
               <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
               <title>Other information</title>
               <text>
                  <list listType="unordered">
                     <item>
                        <caption>•</caption>store at 20-25<sup>°</sup>C (68-77<sup>°</sup>F)</item>
                  </list>
               </text>
               <effectiveTime value="20150824"/>
            </section>
         </component>
         <component>
            <section ID="ID_a4f2b652-bf37-49d9-9881-4ad0fb18406e">
               <id root="a4f2b652-bf37-49d9-9881-4ad0fb18406e"/>
               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>Inactive ingredients</title>
               <text>
                  <paragraph>croscarmellose sodium, crospovidone, FD&amp;C red #40 aluminum lake, FD&amp;C yellow #6 aluminum lake, hypromellose, mica-based pearlescent pigment, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid</paragraph>
               </text>
               <effectiveTime value="20150824"/>
            </section>
         </component>
         <component>
            <section ID="ID_3c08bd28-eda5-4df1-a52e-8513c366e1df">
               <id root="3c08bd28-eda5-4df1-a52e-8513c366e1df"/>
               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <title>Questions or comments?</title>
               <text>
                  <paragraph>1-800-632-6900</paragraph>
               </text>
               <effectiveTime value="20150824"/>
            </section>
         </component>
         <component>
            <section ID="ID_18b2d285-9756-4370-8404-bf6a5b2dd877">
               <id root="18b2d285-9756-4370-8404-bf6a5b2dd877"/>
               <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
               <title>Package/Label Principal Display Panel</title>
               <text>
                  <paragraph>COMPARE TO the active ingredient of EXTRA STRENGTH TYLENOL®</paragraph>
                  <paragraph>See side panel</paragraph>
                  <paragraph>FOR ADULTS</paragraph>
                  <paragraph>Acetaminophen</paragraph>
                  <paragraph>Pain Reliever/Fever Reducer</paragraph>
                  <paragraph>EXTRA STRENGTH Rapid Release</paragraph>
                  <paragraph>Contains No Aspirin</paragraph>
                  <paragraph>actual size</paragraph>
                  <paragraph>24 CAPLETS 500 mg EACH</paragraph>
                  <renderMultiMedia ID="id1204983439" referencedObject="dc56a4f2-e507-4a88-918e-8cf1f232e9-1"/>
                  <renderMultiMedia ID="id-653531768" referencedObject="ID_429a467c-ff28-4d59-9051-d0309cfd6e-1"/>
               </text>
               <effectiveTime value="20150824"/>
               <component>
                  <observationMedia ID="dc56a4f2-e507-4a88-918e-8cf1f232e9-1">
                     <text>Kroger Acetaminophen image 1</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="5bfd9841-c781-43be-b823-d334893ae6ed-01.jpg"/>
                     </value>
                  </observationMedia>
               </component>
               <component>
                  <observationMedia ID="ID_429a467c-ff28-4d59-9051-d0309cfd6e-1">
                     <text>Kroger Acetaminophen image 2</text>
                     <value mediaType="image/jpeg" xsi:type="ED">
                        <reference value="5bfd9841-c781-43be-b823-d334893ae6ed-02.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
         </component>
      </structuredBody>
   </component>
</document>