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                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="1Q73Q2JULR" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SODIUM CITRATE</name>
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                <ingredient classCode="IACT">
                  <ingredientSubstance>
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                <ingredient classCode="IACT">
                  <ingredientSubstance>
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                <ingredient classCode="ACTIB">
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                    <denominator unit="mL" value="20.3"/>
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                    <activeMoiety>
                      <activeMoiety>
                        <code code="362O9ITL9D" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>ACETAMINOPHEN</name>
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                  <author>
                    <territorialAuthority>
                      <territory>
                        <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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                    </territorialAuthority>
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              <subjectOf>
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              <subjectOf>
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          <title>
            <content styleCode="bold">
              <content styleCode="italics">Active ingredient 
   <br/>  (in each 5 mL teaspoonful)
  </content>
            </content>
          </title>
          <text>
            <paragraph>
              <content styleCode="bold">ACETAMINOPHEN</content>160 mg

 </paragraph>
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          <title>
            <content styleCode="italics">
              <content styleCode="bold">Purpose</content>
            </content>
          </title>
          <text>
            <paragraph>Pain reliever/fever reducer</paragraph>
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          <effectiveTime value="20231010"/>
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      <component>
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          <title>
            <content styleCode="italics">
              <content styleCode="bold">Uses</content>
            </content>
          </title>
          <text>
            <paragraph>temporarily relieves minor aches and pains due to:</paragraph>
            <list listType="unordered">
              <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>
            <paragraph>temporarily reduces fever</paragraph>
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          <effectiveTime value="20231010"/>
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      <component>
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          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>
            <content styleCode="italics">
              <content styleCode="bold">Warnings</content>
            </content>
          </title>
          <text/>
          <effectiveTime value="20231010"/>
          <component>
            <section ID="LINK_99114c29-2641-4147-b263-694d118ccd6d">
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              <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
              <title/>
              <text>
                <paragraph>
                  <content styleCode="bold">Liver warning:</content> This product contains acetaminophen. Severe liver damage may occur if:

 </paragraph>
                <list listType="unordered" styleCode="Square">
                  <item>adult takes more than 6 doses in 24 hours, which is the maximum daily amount</item>
                  <item>child takes more than 5 doses in 24 hours</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="20231010"/>
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          </component>
          <component>
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              <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
              <title/>
              <text>
                <paragraph>
                  <content styleCode="bold">Allergy alert:</content>Acetaminophen may cause severe skin reactions. Symptoms may include:                        

 </paragraph>
                <list listType="unordered">
                  <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="20231010"/>
            </section>
          </component>
          <component>
            <section ID="LINK_1914d5ad-6a9d-4260-89ae-81ad4cddf445">
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              <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
              <title/>
              <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="20231010"/>
            </section>
          </component>
          <component>
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              <id root="1f8166c0-62e3-10f8-e063-6394a90a86cf"/>
              <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">
                  <item>with any other drug containing acetaminophen (prescription or nonprescription).</item>
                  <item>if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.</item>
                  <item>for more than 10 days for pain unless directed by a doctor</item>
                  <item>for more than 3 days for fever unless directed by a doctor</item>
                  <item>if you are allergic to acetaminophen or any of the inactive ingredients of this product</item>
                </list>
              </text>
              <effectiveTime value="20231010"/>
            </section>
          </component>
          <component>
            <section ID="LINK_5476ab9d-3491-4092-a01a-1580253ffb8a">
              <id root="1f8166c0-62e4-10f8-e063-6394a90a86cf"/>
              <code code="50569-3" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR SECTION"/>
              <title/>
              <text>
                <paragraph>Ask a doctor before use if the user has liver disease</paragraph>
              </text>
              <effectiveTime value="20231010"/>
            </section>
          </component>
          <component>
            <section ID="LINK_ba2bc1de-05c4-418f-913b-3897fc2d6a4b">
              <id root="1f8166c0-62e5-10f8-e063-6394a90a86cf"/>
              <code code="50568-5" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ASK DOCTOR/PHARMACIST SECTION"/>
              <title/>
              <text>
                <paragraph>Ask a doctor or pharmacist before use if the user is taking the blood thining drug warfarin.</paragraph>
              </text>
              <effectiveTime value="20231010"/>
            </section>
          </component>
          <component>
            <section ID="LINK_2485a19f-fdd3-41a9-92db-f44372fcfc18">
              <id root="1f8166c0-62e6-10f8-e063-6394a90a86cf"/>
              <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">
                  <item>symptoms do not improve</item>
                  <item>new symptoms occur</item>
                  <item>pain or fever persists or gets worse</item>
                </list>
              </text>
              <effectiveTime value="20231010"/>
            </section>
          </component>
          <component>
            <section ID="LINK_5d4cc5a2-61ca-4bd2-b7a8-4c794b6fc56f">
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              <code code="53414-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PREGNANCY OR BREAST FEEDING SECTION"/>
              <title/>
              <text>
                <paragraph>
                  <content styleCode="bold">If pregnant or breast-feeding,</content>ask a health professional before use.

 </paragraph>
              </text>
              <effectiveTime value="20231010"/>
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          </component>
          <component>
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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"/>
              <title/>
              <text>
                <paragraph>
                  <content styleCode="bold">Keep out of reach of children.</content>
                </paragraph>
              </text>
              <effectiveTime value="20231010"/>
            </section>
          </component>
          <component>
            <section ID="LINK_7e99ac87-3660-4b68-9870-f5bda8b49a75">
              <id root="1f8166c0-62e9-10f8-e063-6394a90a86cf"/>
              <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
              <title/>
              <text>
                <paragraph>
                  <content styleCode="bold">Overdose warning:</content>  Taking more than the recommended dose (overdose) may cause liver damage. 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 children even if you do not notice any signs or symptoms.

 </paragraph>
              </text>
              <effectiveTime value="20231010"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section ID="LINK_7a8f474c-46cf-4f7d-bca5-7862da1c70c4">
          <id root="1f8166c0-62ea-10f8-e063-6394a90a86cf"/>
          <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="#LINK_7e99ac87-3660-4b68-9870-f5bda8b49a75">overdose warning</linkHtml>)
  
   </content>
              </item>
            </list>
            <table>
              <col/>
              <col/>
              <thead>
                <tr>
                  <th align="center" styleCode=" Lrule Rrule" valign="top">age</th>
                  <th align="center" styleCode=" Rrule" valign="top">dose</th>
                </tr>
              </thead>
              <tbody>
                <tr>
                  <td styleCode=" Lrule Rrule" valign="top">adults and children 12 years of age and over</td>
                  <td styleCode=" Rrule" valign="top">20.3 mL (650 mg) every 4 to 6 hours 
     <br/>  not to exceed 6 doses in a 24-hour period
    </td>
                </tr>
                <tr>
                  <td styleCode=" Lrule Rrule" valign="top">children 6 to under 12 years of age</td>
                  <td styleCode=" Rrule" valign="top">10.15 mL (325 mg) every 4 hours 
     <br/>  not to exceed 5 doses in a 24-hour period
    </td>
                </tr>
                <tr>
                  <td styleCode=" Lrule Rrule" valign="top">children 4 to under 6 years of age</td>
                  <td styleCode=" Rrule" valign="top">7.5 mL (240 mg) every 4 hours 
     <br/>  not to exceed 5 doses in a 24-hour period
    </td>
                </tr>
                <tr>
                  <td styleCode=" Lrule Rrule" valign="top">children 2 to under 4 years of age</td>
                  <td styleCode=" Rrule" valign="top">5 mL (160 mg) every 4 hours 
     <br/>  not to exceed 5 doses in a 24-hour period
    </td>
                </tr>
                <tr>
                  <td styleCode=" Lrule Rrule" valign="top">children under 2 years of age</td>
                  <td styleCode=" Rrule" valign="top">consult a doctor</td>
                </tr>
              </tbody>
            </table>
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          <effectiveTime value="20231010"/>
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      <component>
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          <id root="1f8166c0-62eb-10f8-e063-6394a90a86cf"/>
          <code code="44425-7" codeSystem="2.16.840.1.113883.6.1" displayName="STORAGE AND HANDLING SECTION"/>
          <title>
            <content styleCode="bold">
              <content styleCode="italics">Other information</content>
            </content>
          </title>
          <text>
            <paragraph>■ ﻿Each 5 mL contains: sodium 2 mg</paragraph>
            <paragraph>■ store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]</paragraph>
            <paragraph>■ keep tightly closed  ■ protect from light</paragraph>
            <paragraph>■ a red, cherry flavored solution supplied in the following oral dosage forms:</paragraph>
            <paragraph>NDC 0121-0657-05:  5 mL unit dose cup</paragraph>
            <paragraph>NDC 0121-0657-00:   Case contains 100 unit dose cups of 5 mL (0121-0657-05) packaged in 10 trays of 10 unit dose cups each.</paragraph>
            <paragraph>NDC 0121-1314-11:  10.15 mL unit dose cup</paragraph>
            <paragraph>NDC 0121-1314-00:   Case contains 100 unit dose cups of 10.15 mL (0121-1314-11) packaged in 10 trays of 10 unit dose cups each.</paragraph>
            <paragraph>NDC 0121-1971-21:  20.3 mL unit dose cup</paragraph>
            <paragraph>NDC 0121-1971-00:   Case contains 100 unit dose cups of 20.3 mL (0121-1971-21) packaged in 10 trays of 10 unit dose cups each.</paragraph>
          </text>
          <effectiveTime value="20231010"/>
        </section>
      </component>
      <component>
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          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>
            <content styleCode="bold">
              <content styleCode="italics">Inactive ingredients:</content>
            </content>
          </title>
          <text>
            <paragraph>Citric acid, FD&amp;C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.</paragraph>
          </text>
          <effectiveTime value="20231010"/>
        </section>
      </component>
      <component>
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          <id root="1f8166c0-62ed-10f8-e063-6394a90a86cf"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>Questions or comments?</title>
          <text>
            <paragraph>Call 1-800-845-8210. You may also report serious side effects to this phone number.</paragraph>
          </text>
          <effectiveTime value="20231010"/>
        </section>
      </component>
      <component>
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          <title>
            <content styleCode="bold">MANUFACTURED BY:</content>
          </title>
          <text>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">Pharmaceutical Associates, Inc.</content>
              </content>
            </paragraph>
            <paragraph>Greenville, SC 29605</paragraph>
            <paragraph>www.paipharma.com</paragraph>
            <paragraph>R10/20</paragraph>
          </text>
          <effectiveTime value="20231010"/>
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      <component>
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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 - 5 mL Cup</title>
          <text>
            <paragraph>Delivers
 
  <content styleCode="bold">5 mL</content>
            </paragraph>
            <paragraph>NDC 0121-0657-05</paragraph>
            <paragraph>
              <content styleCode="bold">Acetaminophen Oral Solution USP</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">160 mg/5 mL</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">ALCOHOL FREE</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Package Not Child-Resistant</content>
            </paragraph>
            <paragraph>PHARMACEUTICAL ASSOCIATES, INC. 
  <br/>  GREENVILLE, SC 29605
 </paragraph>
            <paragraph>
              <content styleCode="bold">SEE INSERT</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">F0657051020</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <renderMultiMedia referencedObject="MM1"/>
              </content>
            </paragraph>
          </text>
          <effectiveTime value="20231010"/>
          <component>
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              <value mediaType="image/jpeg" xsi:type="ED">
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      <component>
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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 - 10 mL Cup</title>
          <text>
            <paragraph>Delivers
 
  <content styleCode="bold">10.15 mL</content>
            </paragraph>
            <paragraph>NDC 0121-1314-11</paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">
                  <content styleCode="bold">Acetaminophen Oral Solution USP</content>
                </content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">325 mg/10.15 mL</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">ALCOHOL FREE</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Package Not Child-Resistant </content>
            </paragraph>
            <paragraph>PHARMACEUTICAL ASSOCIATES, INC. 
  <br/>  GREENVILLE, SC 29605
 </paragraph>
            <paragraph>
              <content styleCode="bold">SEE INSERT</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">F0657111020</content>
            </paragraph>
            <paragraph>
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          <title>PRINCIPAL DISPLAY PANEL - 20.3 mL Cup</title>
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            <paragraph>Delivers
 
  <content styleCode="bold">20.3 mL</content>
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            <paragraph>
              <content styleCode="bold">NDC 0121-1971-21</content>
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            <paragraph>
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            </paragraph>
            <paragraph>650 mg/20.3 mL</paragraph>
            <paragraph>
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                <content styleCode="italics">ALCOHOL FREE</content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Package Not Child-Resistant</content>
            </paragraph>
            <paragraph>PHARMACEUTICAL ASSOCIATES, INC. 
  <br/>  GREENVILLE, SC 29605
 </paragraph>
            <paragraph>
              <content styleCode="bold">SEE INSERT</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">F0657211020</content>
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