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  <title>hst 265 (268)</title>
  <effectiveTime value="20240723"/>
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        <name>GERI-CARE PHARMACEUTICAL CORP</name>
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            <name>GERI-CARE PHARMACEUTICAL CORP</name>
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            <manufacturedProduct>
              <manufacturedProduct>
                <code code="57896-268" codeSystem="2.16.840.1.113883.6.69"/>
                <name>ACETAMINOPHEN</name>
                <formCode code="C42927" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TABLET, EXTENDED RELEASE"/>
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                    <name>ACETAMINOPHEN</name>
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                    <code code="8136Y38GY5" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)</name>
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                    <code code="0WZ8WG20P6" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>HYPROMELLOSE 2910 (6 MPA.S)</name>
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                    <name>POLYETHYLENE GLYCOL 400</name>
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                    <code code="U725QWY32X" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POVIDONE K30</name>
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                    <code code="O8232NY3SJ" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>STARCH, CORN</name>
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                    <code code="AG9B65PV6B" codeSystem="2.16.840.1.113883.4.9"/>
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                    <code code="4ELV7Z65AP" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>STEARIC ACID</name>
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                    <numerator unit="mg" value="650"/>
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                    <name>ACETAMINOPHEN</name>
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                        <name>ACETAMINOPHEN</name>
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                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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                  <value xsi:type="ST">G650</value>
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          <id root="1dee4e3b-7936-6bf1-e063-6394a90a8424"/>
          <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 650 mg</paragraph>
          </text>
          <effectiveTime value="20180112"/>
        </section>
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        <section ID="Section_1">
          <id root="92c21af8-a967-2085-e053-2a95a90a172b"/>
          <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="20180112"/>
        </section>
      </component>
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          <id root="92c24edc-07fa-f191-e053-2995a90a8170"/>
          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>USES</title>
          <text>
            <paragraph>• temporarily relieves minor aches and pains due to:
  <br/>
              <br/>
    • minor pain of arthritis
  <br/>
              <br/>
    • muscular aches
  <br/>
              <br/>
    • backache
  <br/>
              <br/>
    • premenstrual and menstrual cramps
  <br/>
              <br/>
    • the common cold
  <br/>
              <br/>
    • headache
  <br/>
              <br/>
    • toothache
  <br/>
              <br/>
• temporarily reduces fever
 </paragraph>
            <paragraph/>
            <paragraph/>
          </text>
          <effectiveTime value="20190701"/>
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          <id root="92c21af8-a969-2085-e053-2a95a90a172b"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>WARNINGS</title>
          <text>
            <br/>
            <paragraph>
              <content styleCode="bold">Liver warning:</content> This product contains acetaminophen. Severe Liver damage may occur if you take
       
 
  
       
 
  <br/> • more than 6 caplets in 24 hours, which is the maximum daily amount
       
 
  
       
 
  <br/> • with other drugs containing acetaminophen
       
 
  
       
 
  <br/> • 3 or more alcoholic drinks everyday while using this product
      

 
      

 </paragraph>
            <paragraph>
              <content styleCode="bold">Allergy alert:</content> acetaminophen may cause severe skin reactions
       
 
  
       
 
  <br/> Symptoms may include:
       
 
  
       
 
  <br/> • skin reddening 
       
 
  
       
 
  <br/> • blisters  
       
 
  
       
 
  <br/> • rash
       
 
  
       
 
  <br/> If a skin reaction occurs, stop use and seek medical help right away
      

 
      

 </paragraph>
          </text>
          <effectiveTime value="20180112"/>
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          <id root="92c21af8-a96a-2085-e053-2a95a90a172b"/>
          <code code="50570-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - DO NOT USE SECTION"/>
          <title>Do not use</title>
          <text>
            <paragraph>• with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 
       
 
  
       
 
  <br/> • if you are allergic to acetaminophen or any of the inactive ingredients in this product.
      

 
      

 </paragraph>
          </text>
          <effectiveTime value="20180112"/>
        </section>
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          <id root="92c21af8-a96b-2085-e053-2a95a90a172b"/>
          <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="20180112"/>
        </section>
      </component>
      <component>
        <section ID="Section_6">
          <id root="92c21af8-a96c-2085-e053-2a95a90a172b"/>
          <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="20180112"/>
        </section>
      </component>
      <component>
        <section ID="Section_8">
          <id root="92c21af8-a96d-2085-e053-2a95a90a172b"/>
          <code code="50566-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - STOP USE SECTION"/>
          <title>Stop use and ask doctor if</title>
          <text>
            <paragraph>  • pain gets worse or lasts more than 10 days
       
 
  
       
 
  <br/>   • fever gets worse or lasts more than 3 days
       
 
  
       
 
  <br/>   • new symptoms occur
       
 
  
       
 
  <br/>   • redness or swelling is present
       
 
  
       
 
  <br/> These could be signs of a serious condition.
      

 
      

 </paragraph>
          </text>
          <effectiveTime value="20180112"/>
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          <id root="92c21af8-a96e-2085-e053-2a95a90a172b"/>
          <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="20180112"/>
        </section>
      </component>
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        <section ID="Section_11">
          <id root="92c21af8-a96f-2085-e053-2a95a90a172b"/>
          <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>
            <br/>
            <paragraph>
              <content styleCode="bold">Overdose warning: </content>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="20180112"/>
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          <id root="92c2b7c0-670e-9294-e053-2a95a90a7383"/>
          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>DIRECTIONS</title>
          <text>
            <paragraph>
              <content styleCode="bold">• do not take more than directed (see overdose warning)</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Adults:</content> • take 2 caplets every 8 hours with water
  <br/>
• swallow whole; do not crush, chew, split or dissolve
  <br/>
• do not take more than 6 caplets in 24 hours
  <br/>
• do not use for more than 10 days unless directed by a doctor
  <br/>
              <content styleCode="bold">Under 18 years of age:</content> ask a doctor
 </paragraph>
            <paragraph/>
            <paragraph/>
            <paragraph/>
            <paragraph/>
          </text>
          <effectiveTime value="20190917"/>
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          <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
          <title>OTHER INFORMATION</title>
          <text>
            <paragraph>
              <content styleCode="bold">• </content>store between 20-25°C (68-77°F)
 </paragraph>
          </text>
          <effectiveTime value="20180619"/>
        </section>
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          <id root="92c21af8-a972-2085-e053-2a95a90a172b"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>INACTIVE INGREDIENTS</title>
          <text>
            <paragraph>hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid</paragraph>
          </text>
          <effectiveTime value="20180112"/>
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          <id root="92c25e89-1e92-c79a-e053-2a95a90abc84"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>QUESTIONS OR COMMENTS ?</title>
          <text>
            <paragraph>
              <content styleCode="bold">1-800-540-3765</content>
            </paragraph>
          </text>
          <effectiveTime value="20190917"/>
        </section>
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          <title>PRINCIPAL DISPLAY PANEL</title>
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            <paragraph>
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          <effectiveTime value="20190701"/>
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              <text>1</text>
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