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  <code code="34390-5" codeSystem="2.16.840.1.113883.6.1" displayName="HUMAN OTC DRUG LABEL"/>
  <title>Drug Facts</title>
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        <name>Strategic Sourcing Services LLC</name>
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              <manufacturedProduct>
                <code code="62011-0256" codeSystem="2.16.840.1.113883.6.69"/>
                <name>Pain Reliever PM<suffix>Extra Strength</suffix>
                </name>
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                  <genericMedicine>
                    <name>Acetaminophen, Diphenhydramine HCl</name>
                  </genericMedicine>
                </asEntityWithGeneric>
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                    </activeMoiety>
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                        <name>DIPHENHYDRAMINE</name>
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                    <name>HYPROMELLOSES</name>
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                    <name>CELLULOSE, MICROCRYSTALLINE</name>
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                    <name>POLYETHYLENE GLYCOL, UNSPECIFIED</name>
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                    <name>POVIDONE</name>
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                    <name>STEARIC ACID</name>
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                  <ingredientSubstance>
                    <code code="15FIX9V2JP" codeSystem="2.16.840.1.113883.4.9"/>
                    <name>TITANIUM DIOXIDE</name>
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                    <name>CROSCARMELLOSE SODIUM</name>
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                    <name>ALUMINUM OXIDE</name>
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                    <name>SODIUM STARCH GLYCOLATE TYPE A CORN</name>
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          <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/>
          <title>Active ingredients (in each geltab)</title>
          <text>
            <paragraph>
              <content styleCode="bold">Acetaminophen 500 mg</content>
            </paragraph>
            <paragraph>Diphenhydramine HCl 25 mg</paragraph>
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          <title>Purposes</title>
          <text>
            <paragraph>
              <content styleCode="bold">Pain reliever</content>
            </paragraph>
            <paragraph>Nighttime sleep-aid</paragraph>
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          <title>Uses</title>
          <text>
            <paragraph>temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness</paragraph>
          </text>
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          <title>Warnings</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" styleCode="Disk">
              <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" styleCode="Disk">
              <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>
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              <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="Disk">
                  <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>with any other product containing diphenhydramine, even one used on skin 
</item>
                  <item>in children under 12 years of age</item>
                  <item>if you have ever had an allergic reaction to this product or any of its ingredients</item>
                </list>
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              <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" styleCode="Disk">
                  <item>liver disease 
</item>
                  <item>a breathing problem such as emphysema or chronic bronchitis 
</item>
                  <item>trouble urinating due to an enlarged prostate gland 
</item>
                  <item>glaucoma</item>
                </list>
              </text>
              <effectiveTime value="20251008"/>
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              <title>Ask a doctor or pharmacist before use if you are</title>
              <text>
                <list listType="unordered" styleCode="Disk">
                  <item>taking the blood thinning drug warfarin</item>
                  <item>taking sedatives or tranquilizers</item>
                </list>
              </text>
              <effectiveTime value="20251008"/>
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              <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" styleCode="Disk">
                  <item>drowsiness will occur
</item>
                  <item>avoid alcoholic drinks
</item>
                  <item>do not drive a motor vehicle or operate machinery</item>
                </list>
              </text>
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              <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="Disk">
                  <item>sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. 
</item>
                  <item>new symptoms occur 
</item>
                  <item>redness or swelling is present 
</item>
                  <item>pain gets worse or lasts more than 10 days 
</item>
                  <item>fever gets worse or lasts more than 3 days </item>
                </list>
                <paragraph>These could be signs of a serious condition.</paragraph>
              </text>
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              <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>
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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>Keep out of reach of children.</title>
              <text>
                <paragraph>
                  <content styleCode="bold">Overdose warning:</content> In case of overdose, get medical help or contact a Poison Control Center (1-800-22201222) right away: 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="20251008"/>
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          <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="Disk">
              <item>
                <content styleCode="bold">do not take more than directed (see overdose warning) </content>
              </item>
              <item>adults and children 12 years and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours. 
</item>
              <item>children under 12 years: do not use</item>
            </list>
          </text>
          <effectiveTime value="20251008"/>
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          <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="Disk">
              <item>store at room temperature 20º-25ºC (68º-77ºF)
</item>
              <item>avoid high humidity and excessive heat</item>
            </list>
          </text>
          <effectiveTime value="20251008"/>
        </section>
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          <id root="d6ab657f-169e-4279-a13e-78718382b72f"/>
          <code code="51727-6" codeSystem="2.16.840.1.113883.6.1" displayName="INACTIVE INGREDIENT SECTION"/>
          <title>Inactive ingredients</title>
          <text>
            <paragraph>corn starch, croscarmellose sodium*, D&amp;C red #27 aluminum lake, edible black ink, FD&amp;C blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, sodium starch glycolate*, stearic acid, titanium dioxide</paragraph>
            <paragraph>*contains one or more of these ingredients</paragraph>
          </text>
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          <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">1-877-753-3935</content> Monday-Friday 9AM-5PM EST</paragraph>
          </text>
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          <title>Principal Display Panel</title>
          <text>
            <paragraph>Compare to the active ingredients in Extra Strength TYLENOL PM®†</paragraph>
            <paragraph>EXTRA STRENGTH</paragraph>
            <paragraph>
              <content styleCode="bold">Pain Reliever PM</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">ACETAMINOPHEN 500 mg,</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Diphenhydramine HCl 25 mg</content>
            </paragraph>
            <paragraph>Pain reliever/Nighttime sleep-aid </paragraph>
            <paragraph>Non-habit forming • For ages 12 years and over</paragraph>
            <paragraph>GELTABS</paragraph>
            <paragraph>†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol® PM.</paragraph>
            <paragraph>
              <content styleCode="bold">TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.</content>
            </paragraph>
            <paragraph>Distributed by McKesson</paragraph>
            <paragraph>6555 State Highway 161 Irving, TX 75039</paragraph>
            <paragraph>
              <linkHtml href="http://www.healthmart.com">www.healthmart.com</linkHtml>
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