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  <title>VALUMEDS™ REGULAR STRENGTH PAIN RELIEF</title>
  <effectiveTime value="20241212"/>
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          <effectiveTime value="20241212"/>
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              <manufacturedProduct>
                <code code="68210-0120" codeSystem="2.16.840.1.113883.6.69"/>
                <name>REGULAR STRENGTH PAIN RELIEF</name>
                <formCode code="C42936" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CAPSULE, GELATIN COATED"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>ACETAMINOPHEN</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="WZB9127XOA" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>FD&amp;C RED NO. 40</name>
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                </ingredient>
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                    <code code="2G86QN327L" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>GELATIN, UNSPECIFIED</name>
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                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>GLYCERIN</name>
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                    <code code="3WJQ0SDW1A" codeSystem="2.16.840.1.113883.4.9"/>
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                    <name>POVIDONE K30</name>
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                    <code code="6DC9Q167V3" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>PROPYLENE GLYCOL</name>
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                    <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>WATER</name>
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                    <code code="506T60A25R" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SORBITOL</name>
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                    <code code="15FIX9V2JP" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>TITANIUM DIOXIDE</name>
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                    <numerator unit="mg" value="325"/>
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                    <name>ACETAMINOPHEN</name>
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                        <name>ACETAMINOPHEN</name>
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                        <formCode code="C43182" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="CARTON"/>
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                          <statusCode code="active"/>
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                            <low value="20180410"/>
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                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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                    <originalText>OBLONG</originalText>
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          <text>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">Drug Facts</content>
              </content>
            </paragraph>
          </text>
          <effectiveTime value="20180410"/>
        </section>
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          <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 softgel)</content>
          </title>
          <text>
            <paragraph>Acetaminophen 325 mg</paragraph>
          </text>
          <effectiveTime value="20180410"/>
        </section>
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          <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="20180410"/>
        </section>
      </component>
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          <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" 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>
          </text>
          <effectiveTime value="20180410"/>
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          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>
            <content styleCode="bold">Warnings</content>
          </title>
          <effectiveTime value="20180410"/>
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              <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
              <title>
                <content styleCode="bold">Liver warning</content>
              </title>
              <text>
                <paragraph>This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (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>
                </list>
              </text>
              <effectiveTime value="20180410"/>
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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>
                <content styleCode="bold">Allergy alert</content>
              </title>
              <text>
                <paragraph>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>
              </text>
              <effectiveTime value="20180410"/>
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              <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" 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>
                  <item>do not give this product to children for the pain of arthritis unless directed by a doctor</item>
                </list>
              </text>
              <effectiveTime value="20180410"/>
            </section>
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            <section>
              <id root="9af03e06-8ad0-2b72-e053-2995a90ab829"/>
              <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="20160803"/>
            </section>
          </component>
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            <section>
              <id root="9af03e06-8ad1-2b72-e053-2995a90ab829"/>
              <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 the user is </content>taking the blood thinning drug warfarin
        

 
        

 
        

 </paragraph>
              </text>
              <effectiveTime value="20180410"/>
            </section>
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              <id root="9af03e06-8ad2-2b72-e053-2995a90ab829"/>
              <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" 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>
              </text>
              <effectiveTime value="20180410"/>
            </section>
          </component>
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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>
              </text>
              <effectiveTime value="20180410"/>
            </section>
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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>
              </text>
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            </section>
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              <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="20180410"/>
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          <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>
            <list listType="unordered" styleCode="Square">
              <item>
                <content styleCode="bold">do not take more than directed (see 
         
   
    
         
   
    
         
   
    <linkHtml href="#ow">overdose warning</linkHtml>)
        
  
   
        
  
   
        
  
   </content>
              </item>
            </list>
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              <col align="left" valign="top" width="35%"/>
              <col align="left" valign="top" width="65%"/>
              <tbody>
                <tr styleCode="Botrule">
                  <td align="left" styleCode="Lrule Rrule Toprule">adults and children 12 years and over</td>
                  <td align="left" styleCode="Rrule Toprule">
                    <list listType="unordered" styleCode="Square">
                      <item>take 2 softgels every 4 to 6 hours while symptoms last</item>
                      <item>do not take more than 10 softgels in 24 hours</item>
                      <item>do not use for more than 10 days unless directed by a doctor</item>
                    </list>
                  </td>
                </tr>
                <tr styleCode="Botrule">
                  <td align="left" styleCode="Lrule Rrule">children 6-11 years</td>
                  <td align="left" styleCode="Rrule">
                    <list listType="unordered" styleCode="Square">
                      <item>take 1 softgel every 4 to 6 hours while symptoms last</item>
                      <item>do not take more than 5 softgels in 24 hours</item>
                      <item>do not use for more than 5 days unless directed by a doctor</item>
                    </list>
                  </td>
                </tr>
                <tr>
                  <td align="left" styleCode="Botrule Lrule Rrule">children under 6 years</td>
                  <td align="left" styleCode="Botrule Rrule">ask a doctor</td>
                </tr>
              </tbody>
            </table>
            <paragraph/>
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          <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" styleCode="Square">
              <item>store between 20-25°C (68-77°F)</item>
            </list>
          </text>
          <effectiveTime value="20180410"/>
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          <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>FD&amp;C red # 40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide</paragraph>
          </text>
          <effectiveTime value="20180410"/>
        </section>
      </component>
      <component>
        <section>
          <id root="9af03e06-8ad9-2b72-e053-2995a90ab829"/>
          <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>Call 
       
 
  
       
 
  
       
 
  <content styleCode="bold">1-888-333-9792</content>
            </paragraph>
          </text>
          <effectiveTime value="20180410"/>
        </section>
      </component>
      <component>
        <section>
          <id root="9af03e06-8ada-2b72-e053-2995a90ab829"/>
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          <text>
            <paragraph>
              <content styleCode="bold">DISTRIBUTED BY
        
  
   
        
  
   
        
  
   <br/>SPIRIT PHARMACEUTICALS LLC.
       
 
  
       
 
  
       
 
  </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">RONKONKOMA, NY 11779</content>
            </paragraph>
          </text>
          <effectiveTime value="20180410"/>
        </section>
      </component>
      <component>
        <section>
          <id root="9af03e06-8adb-2b72-e053-2995a90ab829"/>
          <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
          <title>PRINCIPAL DISPLAY PANEL - 10 Softgel Bottle Carton</title>
          <text>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">VALUMEDS</content>
              </content>™
      

 
      

 </paragraph>
            <paragraph>
              <content styleCode="bold">COMPARE to the</content> active ingredient in 
       
 
  
       
 
  <br/>
              <content styleCode="bold"> REGULAR STRENGTH TYLENOL®*</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">REGULAR STRENGTH</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">PAIN RELIEF</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Acetaminophen 325 mg</content>
            </paragraph>
            <paragraph>
              <content styleCode="italics">PAIN RELIEVER/FEVER REDUCER</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">10 softgels</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Actual Size</content>
            </paragraph>
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              <text>APAP</text>
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