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  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <title>Infants' TYLENOL 
 <sup>®</sup>
  </title>
  <effectiveTime value="20250220"/>
  <setId root="f9de7c2f-016b-4f40-8b5e-141ad194be97"/>
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    <time/>
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        <name>Kenvue Brands LLC</name>
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                <name>Infants TYLENOL</name>
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                <asEntityWithGeneric>
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                    <name>acetaminophen</name>
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                    <numerator unit="mg" value="160"/>
                    <denominator unit="mL" value="5"/>
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                    <code code="362O9ITL9D" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>ACETAMINOPHEN</name>
                    <activeMoiety>
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                        <name>ACETAMINOPHEN</name>
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                    <name>ANHYDROUS CITRIC ACID</name>
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                    <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>GLYCERIN</name>
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                    <code code="OP1R32D61U" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>MICROCRYSTALLINE CELLULOSE</name>
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                    <code code="1VPU26JZZ4" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>POTASSIUM SORBATE</name>
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                    <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>WATER</name>
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                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="8KW3E207O2" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SORBITOL SOLUTION</name>
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                    <code code="96K6UQ3ZD4" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SUCRALOSE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
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                    <code code="C151H8M554" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SUCROSE</name>
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                    <denominator value="1"/>
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                            <low value="20170626"/>
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                    <numerator unit="mL" value="60"/>
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                <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>
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                  <statusCode code="active"/>
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                    <low value="20170626"/>
                  </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>Dye Free</originalText>
                  </value>
                </characteristic>
              </subjectOf>
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                <characteristic classCode="OBS">
                  <code code="SPLFLAVOR" codeSystem="2.16.840.1.113883.1.11.19255"/>
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                    <originalText/>
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              <consumedIn>
                <substanceAdministration>
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                </substanceAdministration>
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        <section>
          <id root="d0891aa0-ecbe-68c8-e053-2a95a90a4ca9"/>
          <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
          <text>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">Drug Facts</content>
              </content>
            </paragraph>
          </text>
          <effectiveTime value="20200918"/>
        </section>
      </component>
      <component>
        <section>
          <id root="d0891aa0-ecbf-68c8-e053-2a95a90a4ca9"/>
          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>Active ingredient (in each 5 mL)</title>
          <text>
            <paragraph>Acetaminophen 160 mg</paragraph>
          </text>
          <effectiveTime value="20200918"/>
        </section>
      </component>
      <component>
        <section>
          <id root="d0891aa0-ecc0-68c8-e053-2a95a90a4ca9"/>
          <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="20200918"/>
        </section>
      </component>
      <component>
        <section>
          <id root="d0891aa0-ecc1-68c8-e053-2a95a90a4ca9"/>
          <code code="34067-9" codeSystem="2.16.840.1.113883.6.1" displayName="INDICATIONS &amp; USAGE SECTION"/>
          <title>Uses</title>
          <text>
            <paragraph>temporarily:</paragraph>
            <list listType="unordered" styleCode="Square">
              <item>reduces fever</item>
              <item>relieves minor aches and pains due to:
        
  
   
        
  
   <list listType="unordered" styleCode="Square">
                  <item>the common cold</item>
                  <item>flu</item>
                  <item>headache</item>
                  <item>sore throat</item>
                  <item>toothache</item>
                </list>
              </item>
            </list>
          </text>
          <effectiveTime value="20200918"/>
        </section>
      </component>
      <component>
        <section>
          <id root="d0891aa0-ecc2-68c8-e053-2a95a90a4ca9"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>Warnings</title>
          <effectiveTime value="20200918"/>
          <component>
            <section>
              <id root="d0891aa0-ecc3-68c8-e053-2a95a90a4ca9"/>
              <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. Severe liver damage may occur if your child takes</paragraph>
                <list listType="unordered" styleCode="Square">
                  <item>more than 5 doses in 24 hours, which is the maximum daily amount</item>
                  <item>with other drugs containing acetaminophen</item>
                </list>
              </text>
              <effectiveTime value="20200918"/>
            </section>
          </component>
          <component>
            <section>
              <id root="d0891aa0-ecc4-68c8-e053-2a95a90a4ca9"/>
              <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">Allergy alert:</content> acetaminophen may cause severe skin reactions.
        

 
        

 </paragraph>
                <paragraph>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="20200918"/>
            </section>
          </component>
          <component>
            <section>
              <id root="d0891aa0-ecc5-68c8-e053-2a95a90a4ca9"/>
              <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">Sore throat warning:</content> if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
        

 
        

 </paragraph>
              </text>
              <effectiveTime value="20200918"/>
            </section>
          </component>
          <component>
            <section>
              <id root="d0891aa0-ecc6-68c8-e053-2a95a90a4ca9"/>
              <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 your child is allergic to acetaminophen or any of the inactive ingredients in this product</item>
                </list>
              </text>
              <effectiveTime value="20200918"/>
            </section>
          </component>
          <component>
            <section>
              <id root="d0891aa0-ecc7-68c8-e053-2a95a90a4ca9"/>
              <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 your child has</content> liver disease
        

 
        

 </paragraph>
              </text>
              <effectiveTime value="20200918"/>
            </section>
          </component>
          <component>
            <section>
              <id root="d0891aa0-ecc8-68c8-e053-2a95a90a4ca9"/>
              <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 your child is</content> taking the blood thinning drug warfarin
        

 
        

 </paragraph>
              </text>
              <effectiveTime value="20200918"/>
            </section>
          </component>
          <component>
            <section>
              <id root="d0891aa0-ecc9-68c8-e053-2a95a90a4ca9"/>
              <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">When using this product do not exceed recommended dose (see 
          
  
   
          
  
   <linkHtml href="#overdose">overdose warning</linkHtml>)
         
 
  
         
 
  </content>
                </paragraph>
              </text>
              <effectiveTime value="20200918"/>
            </section>
          </component>
          <component>
            <section>
              <id root="d0891aa0-ecca-68c8-e053-2a95a90a4ca9"/>
              <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 5 days</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="20200918"/>
            </section>
          </component>
          <component>
            <section>
              <id root="d0891aa0-eccb-68c8-e053-2a95a90a4ca9"/>
              <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="20200918"/>
            </section>
          </component>
          <component>
            <section ID="overdose">
              <id root="d0891aa0-eccc-68c8-e053-2a95a90a4ca9"/>
              <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>
              </text>
              <effectiveTime value="20200918"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section>
          <id root="d0891aa0-eccd-68c8-e053-2a95a90a4ca9"/>
          <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">this product does not contain directions or complete warnings for adult use.</content>
              </item>
              <item>
                <content styleCode="bold">do not give more than directed (see 
         
   
    
         
   
    <linkHtml href="#overdose">overdose warning</linkHtml>)
        
  
   
        
  
   </content>
              </item>
              <item>
                <content styleCode="bold">shake well before using</content>
              </item>
              <item>mL = milliliter</item>
              <item>find right dose on chart. If possible, use weight to dose; otherwise, use age.</item>
              <item>push air out of syringe. Insert syringe tip into bottle opening</item>
              <item>flip bottle upside down. Pull yellow part of syringe to correct dose</item>
              <item>dispense liquid slowly into child's mouth, toward inner cheek</item>
              <item>repeat dose every 4 hours while symptoms last</item>
              <item>do not give more than 5 times in 24 hours</item>
              <item>replace cap tightly to maintain child resistance</item>
            </list>
            <table width="75%">
              <caption>Dosing Chart</caption>
              <col align="center" valign="top" width="33%"/>
              <col align="center" valign="top" width="34%"/>
              <col align="center" valign="top" width="33%"/>
              <thead>
                <tr>
                  <th styleCode="Lrule Rrule">Weight (lb)</th>
                  <th styleCode="Rrule">Age (yr)</th>
                  <th styleCode="Rrule">Dose (mL)
          
    
     
          
    
     <footnote ID="K674">or as directed by a doctor</footnote>
                  </th>
                </tr>
              </thead>
              <tbody>
                <tr styleCode="Botrule">
                  <td styleCode="Lrule Rrule">under 24</td>
                  <td styleCode="Rrule">under 2 years</td>
                  <td styleCode="Rrule">ask a doctor</td>
                </tr>
                <tr>
                  <td styleCode="Lrule Rrule">24-35 lbs</td>
                  <td styleCode="Rrule">2-3 years</td>
                  <td styleCode="Rrule">5 mL</td>
                </tr>
              </tbody>
            </table>
          </text>
          <effectiveTime value="20200918"/>
          <component>
            <section>
              <id root="d0891aa0-ecce-68c8-e053-2a95a90a4ca9"/>
              <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
              <text>
                <paragraph>
                  <content styleCode="bold">Attention:</content> use only enclosed syringe specifically designed for use with this product.
        

 
        

 </paragraph>
                <paragraph>Do not use any other dosing device.</paragraph>
              </text>
              <effectiveTime value="20200918"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section>
          <id root="d0891aa0-eccf-68c8-e053-2a95a90a4ca9"/>
          <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 carton tape or bottle wrap imprinted with "TYLENOL" is broken or missing</content>
              </item>
            </list>
          </text>
          <effectiveTime value="20200918"/>
        </section>
      </component>
      <component>
        <section>
          <id root="d0891aa0-ecd0-68c8-e053-2a95a90a4ca9"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>Inactive ingredients</title>
          <text>
            <paragraph>anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum</paragraph>
          </text>
          <effectiveTime value="20200918"/>
        </section>
      </component>
      <component>
        <section>
          <id root="d0891aa0-ecd1-68c8-e053-2a95a90a4ca9"/>
          <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">1-800-458-1635</content> (toll-free) or 
       
 
  
       
 
  <content styleCode="bold">215-273-8755</content> (collect)
      

 
      

 </paragraph>
          </text>
          <effectiveTime value="20200918"/>
        </section>
      </component>
      <component>
        <section ID="id_link_d08b2670-c47f-5663-e053-2a95a90a7fb8">
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          <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>NDC 50580-599-03</paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Infants'
   <br/>
TYLENOL 
   <sup>®</sup>
              </content>
              <br/>
For Children
 </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Acetaminophen 160 mg per 5 mL </content>Oral Suspension
  <br/>
Pain Reliever-Fever Reducer
 </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">DYE-FREE</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Pain+Fever</content>
            </paragraph>
            <paragraph/>
            <paragraph>Infants</paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Free Of:</content>
            </paragraph>
            <list listType="unordered">
              <item>Dyes</item>
              <item>Alcohol</item>
              <item>Ibuprofen</item>
              <item>Aspirin</item>
              <item>Parabens</item>
              <item>High Fructose </item>
            </list>
            <paragraph>     Corn Syrup</paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">SimpleMeasure 
   <sup>®</sup>
              </content>
              <br/>
Specially designed for younger children
 </paragraph>
            <paragraph/>
            <paragraph>Use Only Enclosed Syringe
  <br/>
              <br/>
*Same as Children's TYLENOL
 </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">1</content> fl oz (
  <content styleCode="bold">30</content> mL)
  <br/>
160 mg per 5 mL*
 </paragraph>
            <paragraph/>
            <paragraph>
              <content styleCode="bold">Cherry</content>
              <br/>
Flavor
 </paragraph>
            <paragraph>
              <renderMultiMedia referencedObject="img_d08b2080-d10a-ecf0-e053-2995a90ab5b8"/>
            </paragraph>
          </text>
          <effectiveTime value="20200918"/>
          <component>
            <observationMedia ID="img_d08b2080-d10a-ecf0-e053-2995a90ab5b8">
              <text>tylenol-01</text>
              <value mediaType="image/jpeg" xsi:type="ED">
                <reference value="tylenol-01.jpg"/>
              </value>
            </observationMedia>
          </component>
        </section>
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