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   <title>TYLENOL Regular Strength</title>
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            <name>Johnson &amp; Johnson Consumer Inc.</name>
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                        <name>TYLENOL<suffix>Regular Strength</suffix>
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                              <code code="15FIX9V2JP" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>TITANIUM DIOXIDE</name>
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                              <name>SODIUM STARCH GLYCOLATE TYPE A</name>
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                              <name>ACETAMINOPHEN</name>
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                           <author>
                              <territorialAuthority>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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                              <originalText>White with red print</originalText>
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                           <value xsi:type="ST">Tylenol;325</value>
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               <text>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Drug Facts</content>
                     </content>
                  </paragraph>
               </text>
               <effectiveTime value="20210405"/>
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               <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 325 mg</paragraph>
               </text>
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               <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="20210405"/>
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               <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
               <title>Uses</title>
               <text>
                  <list listType="unordered" styleCode="Square">
                     <item>temporarily relieves minor aches and pains due to: 						
        
  
   <list listType="unordered" styleCode="Square">
                           <item>headache</item>
                           <item>muscular aches</item>
                           <item>backache</item>
                           <item>minor pain of arthritis</item>
                           <item>the common cold</item>
                           <item>toothache</item>
                           <item>premenstrual and menstrual cramps</item>
                        </list>
                     </item>
                     <item>temporarily reduces fever</item>
                  </list>
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               <title>Warnings</title>
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                     <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
                     <title>Liver warning</title>
                     <text>
                        <paragraph>This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (1,625 mg) in 24 hours for children. Severe liver damage may occur if</paragraph>
                        <list listType="unordered" styleCode="Square">
                           <item>adult takes more than 4,000 mg of acetaminophen in 24 hours</item>
                           <item>child takes more than 5 doses in 24 hours, which is the maximum daily amount</item>
                           <item>taken with other drugs containing acetaminophen</item>
                           <item>adult has 3 or more alcoholic drinks every day while using this product</item>
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                        <paragraph>
                           <content styleCode="bold">Allergy alert:</content> acetaminophen may cause severe skin reactions. Symptoms may include:
        

 </paragraph>
                        <list listType="unordered" styleCode="Square">
                           <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>
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                     <effectiveTime value="20210405"/>
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                     <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" styleCode="Square">
                           <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>
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                     <effectiveTime value="20210405"/>
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                     <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 the user has</content> liver disease
        

 </paragraph>
                     </text>
                     <effectiveTime value="20210405"/>
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                  <section>
                     <id root="da40aeb9-d333-17db-e053-2995a90a25e3"/>
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                     <text>
                        <paragraph>
                           <content styleCode="bold">Ask a doctor or pharmacist before use if the user is</content> taking the blood thinning drug warfarin
        

 </paragraph>
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                     <effectiveTime value="20210405"/>
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                     <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" styleCode="Square">
                           <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>
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                     <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>
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                     <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>
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         <component>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>Overdose warning</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>
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>Directions</title>
               <text>
                  <list listType="unordered" styleCode="Square">
                     <item>
                        <content styleCode="bold">do not take more than directed (see 
         
   
    <linkHtml href="#od">overdose warning</linkHtml>)
        
  
   </content>
                     </item>
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                     <col width="20%" align="left" valign="top"/>
                     <col width="80%" align="left" valign="top"/>
                     <tbody>
                        <tr styleCode="Botrule">
                           <td styleCode="Rrule">adults and children 12 years and over</td>
                           <td>
                              <list listType="unordered" styleCode="Square">
                                 <item>take 2 caplets every 4 to 6 hours while symptoms last</item>
                                 <item>do not take more than 10 caplets 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 styleCode="Botrule">
                           <td styleCode="Rrule">children 6 years to under 12 years</td>
                           <td>
                              <list listType="unordered" styleCode="Square">
                                 <item>take 1 caplet every 4 to 6 hours while symptoms last</item>
                                 <item>do not take more than 5 caplets in 24 hours</item>
                                 <item>do not use for more than 5 days unless directed by a doctor</item>
                              </list>
                           </td>
                        </tr>
                        <tr>
                           <td styleCode="Rrule">children under 6 years</td>
                           <td>ask a doctor</td>
                        </tr>
                     </tbody>
                  </table>
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               <effectiveTime value="20210405"/>
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               <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" styleCode="Square">
                     <item>store between 20-25°C (68-77°F)</item>
                     <item>
                        <content styleCode="bold">do not use if blister unit is torn or broken</content>
                     </item>
                  </list>
               </text>
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               <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
               <title>Inactive ingredients</title>
               <text>
                  <paragraph>carnauba wax, corn starch, FD&amp;C red no. 40 aluminum lake, hypromellose, magnesium stearate, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide</paragraph>
               </text>
               <effectiveTime value="20210405"/>
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               <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
               <title>Questions or comments?</title>
               <text>
                  <paragraph>Call 
       
 
  <content styleCode="bold">1-877-895-3665</content> (toll-free) or 
       
 
  <content styleCode="bold">215-273-8755</content> (collect)
      

 </paragraph>
               </text>
               <effectiveTime value="20210405"/>
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            <section>
               <id root="da40aeb9-d33c-17db-e053-2995a90a25e3"/>
               <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>325mg</paragraph>
                  <paragraph>NDC 50580-458-11 
       
 
  <br/>To re-order reference the NDC Code
      

 </paragraph>
                  <paragraph>TYLENOL
       
 
  <sup>®</sup>
                  </paragraph>
                  <paragraph>Acetaminophen Pain Reliever - Fever Reducer</paragraph>
                  <paragraph>Regular Strength</paragraph>
                  <paragraph>100 Caplets
       
 
  <br/> 325 mg each
      

 </paragraph>
                  <paragraph>10 Blister Cards
       
 
  <br/> with 
       
 
  <br/>10 Individual Blisters
      

 </paragraph>
                  <paragraph>SMART PACKAGING
       
 
  <br/> DESIGNED FOR HEALTH 
       
 
  <br/>CARE PROFESSIONALS
      

 </paragraph>
                  <paragraph>FOR HOSPITAL AND GOVERNMENT USE ONLY</paragraph>
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               <effectiveTime value="20210405"/>
               <component>
                  <observationMedia ID="MM1">
                     <text>Principal Display Panel</text>
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