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  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <title>
    <content styleCode="italics">Drug Facts</content>
  </title>
  <effectiveTime value="20251125"/>
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    <time/>
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      <representedOrganization>
        <id extension="079944263" root="1.3.6.1.4.1.519.1"/>
        <name>Haleon US Holdings LLC</name>
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          <assignedOrganization/>
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          <subject>
            <manufacturedProduct>
              <manufacturedProduct>
                <code code="0067-8205" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Theraflu Flu Relief Max Strength
<suffix>Nighttime</suffix>
                </name>
                <formCode code="C42996" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="SYRUP"/>
                <asEntityWithGeneric>
                  <genericMedicine>
                    <name>Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr</name>
                  </genericMedicine>
                </asEntityWithGeneric>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="K679OBS311" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED</name>
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                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="PDC6A3C0OX" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>GLYCERIN</name>
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                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="Y9H1V576FH" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>HONEY</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="B2138XJ83G" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>PEG-10 .BETA.-SITOSTERYL ETHER</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="6DC9Q167V3" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>PROPYLENE GLYCOL</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="059QF0KO0R" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>WATER</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="OJ245FE5EU" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SODIUM BENZOATE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="1Q73Q2JULR" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SODIUM CITRATE, UNSPECIFIED FORM</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="R6Q3791S76" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SODIUM GLUCONATE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="96K6UQ3ZD4" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>SUCRALOSE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="TTV12P4NEE" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>XANTHAN GUM</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="IACT">
                  <ingredientSubstance>
                    <code code="U6WSN5SQ1Z" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>ZINC GLUCONATE</name>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="mg" value="1000"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="362O9ITL9D" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>ACETAMINOPHEN</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="362O9ITL9D" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>ACETAMINOPHEN</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="mg" value="4"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="V1Q0O9OJ9Z" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>CHLORPHENIRAMINE MALEATE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="3U6IO1965U" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>CHLORPHENIRAMINE</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <ingredient classCode="ACTIB">
                  <quantity>
                    <numerator unit="mg" value="30"/>
                    <denominator unit="mL" value="30"/>
                  </quantity>
                  <ingredientSubstance>
                    <code code="9D2RTI9KYH" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>DEXTROMETHORPHAN HYDROBROMIDE</name>
                    <activeMoiety>
                      <activeMoiety>
                        <code code="7355X3ROTS" codeSystem="2.16.840.1.113883.4.9"/>
                        <name>DEXTROMETHORPHAN</name>
                      </activeMoiety>
                    </activeMoiety>
                  </ingredientSubstance>
                </ingredient>
                <asContent>
                  <quantity>
                    <numerator unit="mL" value="245.5"/>
                    <denominator value="1"/>
                  </quantity>
                  <containerPackagedProduct>
                    <code code="0067-8205-01" codeSystem="2.16.840.1.113883.6.69"/>
                    <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/>
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                    <characteristic>
                      <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/>
                      <value code="C102834" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 1: Convenience Kit of Co-Package" xsi:type="CV"/>
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                  </subjectOf>
                  <subjectOf>
                    <marketingAct>
                      <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                      <statusCode code="active"/>
                      <effectiveTime>
                        <low value="20220627"/>
                      </effectiveTime>
                    </marketingAct>
                  </subjectOf>
                </asContent>
              </manufacturedProduct>
              <subjectOf>
                <approval>
                  <id extension="M012" 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>
                  </author>
                </approval>
              </subjectOf>
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                  <statusCode code="active"/>
                  <effectiveTime>
                    <low value="20220627"/>
                  </effectiveTime>
                </marketingAct>
              </subjectOf>
              <subjectOf>
                <characteristic classCode="OBS">
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                  <value code="C73365" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BERRY" xsi:type="CE">
                    <originalText>Elderberry</originalText>
                  </value>
                </characteristic>
              </subjectOf>
              <consumedIn>
                <substanceAdministration>
                  <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ORAL"/>
                </substanceAdministration>
              </consumedIn>
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        </section>
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      <component>
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          <id root="446e5d67-95ca-e039-e063-6294a90a6cfa"/>
          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>
            <content styleCode="italics">Active ingredients (in each 30 mL)</content>
          </title>
          <text>
            <paragraph>Acetaminophen 1000 mg</paragraph>
            <paragraph>Chlorpheniramine maleate 4 mg</paragraph>
            <paragraph>Dextromethorphan HBr 30 mg</paragraph>
          </text>
          <effectiveTime value="20230227"/>
        </section>
      </component>
      <component>
        <section ID="ID_4659791a-575d-4842-98b1-df67d66f24a6">
          <id root="446e5d67-95cb-e039-e063-6294a90a6cfa"/>
          <code code="55105-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - PURPOSE SECTION"/>
          <title>
            <content styleCode="italics">Purposes</content>
          </title>
          <text>
            <paragraph>Pain reliever/Fever reducer</paragraph>
            <paragraph>Antihistamine</paragraph>
            <paragraph>Cough suppressant</paragraph>
          </text>
          <effectiveTime value="20230227"/>
        </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="italics">Uses</content>
          </title>
          <text>
            <list listType="unordered">
              <item>temporarily relieves these symptoms due to a common cold:
  
   <list listType="unordered">
                  <item>headache</item>
                  <item>minor aches and pains</item>
                  <item>cough due to minor throat and bronchial irritation</item>
                  <item>minor sore throat pain</item>
                  <item>runny nose</item>
                </list>
              </item>
              <item>temporarily reduces fever</item>
            </list>
          </text>
          <effectiveTime value="20250113"/>
        </section>
      </component>
      <component>
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          <id root="446e5d67-95cd-e039-e063-6294a90a6cfa"/>
          <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
          <title>
            <content styleCode="italics">Warnings</content>
          </title>
          <text>
            <paragraph>
              <content styleCode="bold">Liver warning:</content>This product contains acetaminophen. Severe liver damage may occur if you take

 </paragraph>
            <list listType="unordered">
              <item>more than 4,000 mg of acetaminophen in 24 hours</item>
              <item>with other drugs containing acetaminophen</item>
              <item>3 or more alcoholic drinks every day while using this product</item>
            </list>
            <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>
              <item>If a skin reaction occurs, stop use and seek medical help right away.</item>
            </list>
            <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="20250113"/>
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              <id root="446e5d67-95ce-e039-e063-6294a90a6cfa"/>
              <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">
                  <item>in a child under 12 years of age</item>
                  <item>if you are allergic to acetaminophen</item>
                  <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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.</item>
                </list>
              </text>
              <effectiveTime value="20230227"/>
            </section>
          </component>
          <component>
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              <id root="446e5d67-95cf-e039-e063-6294a90a6cfa"/>
              <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>
                <list listType="unordered">
                  <item>liver disease</item>
                  <item>glaucoma</item>
                  <item>trouble urinating due to an enlarged prostate gland</item>
                  <item>a breathing problem such as emphysema or chronic bronchitis</item>
                  <item>cough that occurs with too much phlegm (mucus)</item>
                  <item>cough that lasts or is chronic such as occurs with smoking, asthma or emphysema</item>
                </list>
              </text>
              <effectiveTime value="20250113"/>
            </section>
          </component>
          <component>
            <section ID="ID_3744e114-704b-45bd-8a23-7ef060e0d5ed">
              <id root="446e5d67-95d0-e039-e063-6294a90a6cfa"/>
              <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>
                <list listType="unordered">
                  <item>taking the blood thinning drug warfarin</item>
                  <item>taking sedatives or tranquilizers</item>
                </list>
              </text>
              <effectiveTime value="20250113"/>
            </section>
          </component>
          <component>
            <section ID="ID_14b645c5-128f-4933-9fbd-db034da6f094">
              <id root="446e5d67-95d1-e039-e063-6294a90a6cfa"/>
              <code code="50567-7" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - WHEN USING SECTION"/>
              <title>When using this product</title>
              <text>
                <list listType="unordered">
                  <item>avoid alcoholic drinks</item>
                  <item>marked drowsiness may occur</item>
                  <item>alcohol, sedatives and tranquilizers may increase drowsiness</item>
                  <item>be careful when driving a motor vehicle or operating machinery</item>
                  <item>excitability may occur, especially in children</item>
                </list>
              </text>
              <effectiveTime value="20250113"/>
            </section>
          </component>
          <component>
            <section ID="ID_47224984-eb0e-4438-ae67-e1d127443c84">
              <id root="446e5d67-95d2-e039-e063-6294a90a6cfa"/>
              <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">
                  <item>pain or cough gets worse or lasts more than 7 days</item>
                  <item>fever gets worse or lasts more than 3 days</item>
                  <item>redness or swelling is present</item>
                  <item>new symptoms occur</item>
                  <item>cough comes back or occurs with rash or headache that lasts.</item>
                  <item>These could be signs of a serious condition.</item>
                </list>
              </text>
              <effectiveTime value="20230227"/>
            </section>
          </component>
          <component>
            <section ID="ID_5316333e-0fcb-467f-be50-5bb54a3a19b3">
              <id root="446e5d67-95d3-e039-e063-6294a90a6cfa"/>
              <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="20230227"/>
            </section>
          </component>
          <component>
            <section ID="ID_64469f19-cd29-4bdf-b6cc-2563c6bc007c">
              <id root="446e5d67-95d4-e039-e063-6294a90a6cfa"/>
              <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>
                <paragraph>In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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="20230227"/>
            </section>
          </component>
        </section>
      </component>
      <component>
        <section ID="ID_ffd7b40e-174b-42bd-b035-10f69c35c8fe">
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          <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
          <title>
            <content styleCode="italics">Directions</content>
          </title>
          <text>
            <list listType="unordered">
              <item>
                <content styleCode="bold">do not use more than directed</content>
              </item>
              <item>measure the dose correctly using the enclosed dosing cup</item>
              <item>adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist</item>
              <item>do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor</item>
              <item>children under 12 years of age: do not use</item>
            </list>
            <table styleCode="Noautorules" width="100%">
              <col width="49%"/>
              <col width="49%"/>
              <tbody>
                <tr>
                  <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top">
                    <paragraph>Age</paragraph>
                  </td>
                  <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top">
                    <paragraph>Dose</paragraph>
                  </td>
                </tr>
                <tr>
                  <td align="center" styleCode="Rrule Lrule Botrule " valign="top">
                    <paragraph>adults and children 12 years of age and over</paragraph>
                  </td>
                  <td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top">
                    <paragraph>30 mL</paragraph>
                  </td>
                </tr>
                <tr>
                  <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top">
                    <paragraph>children under 12 years of age</paragraph>
                  </td>
                  <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top">
                    <paragraph>do not use</paragraph>
                  </td>
                </tr>
              </tbody>
            </table>
          </text>
          <effectiveTime value="20250113"/>
        </section>
      </component>
      <component>
        <section ID="ID_6d825aef-41a5-4ddd-a857-d1ece2011fc2">
          <id root="446e5d67-95d6-e039-e063-6294a90a6cfa"/>
          <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
          <title>
            <content styleCode="italics">Other information</content>
          </title>
          <text>
            <list listType="unordered">
              <item>
                <content styleCode="bold">each 30 mL contains</content>: potassium 5 mg, sodium 34 mg
 
  </item>
              <item>store at controlled room temperature 20-25°C (68-77°F)</item>
            </list>
          </text>
          <effectiveTime value="20250113"/>
        </section>
      </component>
      <component>
        <section ID="ID_59a45074-4965-4b5b-b851-b77c1edad6d6">
          <id root="446e5d67-95d7-e039-e063-6294a90a6cfa"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>
            <content styleCode="italics">Inactive ingredients</content>
          </title>
          <text>
            <paragraph>anhydrous citric acid, carboxymethylcellulose sodium, glycerin, nautral and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate</paragraph>
          </text>
          <effectiveTime value="20250113"/>
        </section>
      </component>
      <component>
        <section ID="ID_216b541f-b929-496c-a05e-a833e095daf8">
          <id root="446e5d67-95d8-e039-e063-6294a90a6cfa"/>
          <code code="53413-1" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - QUESTIONS SECTION"/>
          <title>
            <content styleCode="italics">Questions or comments?</content>
          </title>
          <text>
            <paragraph>
              <content styleCode="bold">1-855-328-5259</content>
            </paragraph>
          </text>
          <effectiveTime value="20230227"/>
        </section>
      </component>
      <component>
        <section ID="ID_a67bc2d0-25dc-4c5b-9d53-fa8454590da8">
          <id root="446e5d67-95d9-e039-e063-6294a90a6cfa"/>
          <code code="60561-8" codeSystem="2.16.840.1.113883.6.1" displayName="OTHER SAFETY INFORMATION"/>
          <title>Additional Information</title>
          <text>
            <paragraph>
              <content styleCode="bold">DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD. USE AS DIRECTED</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">PEEL BACK HERE</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">*Maximum Strength per 6 hour dose.</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">PARENTS:</content>Learn about teen medicine abuse

 </paragraph>
            <paragraph>www.StopMedicineAbuse.org</paragraph>
          </text>
          <effectiveTime value="20250113"/>
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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>
              <content styleCode="bold">
                <content styleCode="italics">THERAFLU</content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">FLU RELIEF</content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">MAX STRENGTH*</content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <content styleCode="italics">NIGHTTIME</content>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Acetaminophen</content>
            </paragraph>
            <paragraph>Pain Reliever/Fever Reducer</paragraph>
            <paragraph>
              <content styleCode="bold">Chlorpheniramine Maleate</content>
            </paragraph>
            <paragraph>Antihistamine</paragraph>
            <paragraph>
              <content styleCode="bold">Dextromethorphan HBr</content>
            </paragraph>
            <paragraph>Cough Suppressant</paragraph>
            <paragraph>HELPS YOU REST**</paragraph>
            <paragraph>
              <content styleCode="bold">Powerful
  
   <content styleCode="italics">fever fighting</content>
              </content>
              <content styleCode="bold">formula that relieves:</content>
            </paragraph>
            <paragraph>/ Body ache</paragraph>
            <paragraph>/ Headache</paragraph>
            <paragraph>/ Sore throat pain</paragraph>
            <paragraph>/ Cough</paragraph>
            <paragraph>/ Runny nose</paragraph>
            <paragraph>
              <content styleCode="bold">Honey &amp; Elderberry Flavor</content>
            </paragraph>
            <paragraph>8.3 FL OZ (245.5 mL)</paragraph>
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          </text>
          <effectiveTime value="20251125"/>
          <component>
            <observationMedia ID="BC43E200-E5D3-4C68-83FD-2250AD0752E2">
              <text>Theraflu Flu Relief Max Strength Nighttime 8.3 oz</text>
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              </value>
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