Label: CHILDRENS CHEWABLE MAPAP - acetaminophen tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 23, 2011

If you are a consumer or patient please visit this version.

  • Active Ingredient (in each chewable tablet)

    Acetaminophen 80 mg

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  • Purposes

    Pain Reliever/Fever Reducer

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  • Uses

    Temporarily relieves minor aches and pain due to:

    ■ The common cold  ■ Flu  ■ Headache  ■ Sore throat

    ■ Toothache

    Temporarily reduces fever.

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  • Warnings

    This product contains acetaminophen. Severe liver damage may occur if your child takes ■ more than 5 doses in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen. Liver warning:

    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. Sore throat warning:

    ■ with any other other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if your child is allergic to acetaminophen or any of the inactive ingredients in this product. Do not use

    liver disease.


    Ask a doctor before use if your child has

    taking the blood thinning drug warfarin.


    Ask a doctor or pharmacist before use if your child is

    When using this product: Do not exceed recommended dose.

    ■ Pain gets worse or lasts more than 5 days ■ Fever gets worse or lasts more than 3 days ■ New symptoms occur ■ Redness or swelling is present Stop use and ask a doctor if

    These could be signs of a serious condition.

    Keep out of reach of children.

    Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800- 222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms. Overdose warning:

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  • Directions

    ■ ■ Find right dose on the chart below. If possible, use weight to dose; otherwise, use age. ■ Chew before swallowing ■ If needed, repeat dose every 4 hours while symptoms lasts ■ Do not give more than 5 times in 24 hours ■ Do not give for more than 5 days unless directed by a doctor. This products does not contain directions or complete warnings for adult use.





    Weight Age Tablets
    Under 24 lbs
    Under 2 years
    Ask a doctor
    24-35 lbs
    2-3 years
    2 tablets
    36-47 lbs
    4-5 years
    3 tablets
    48-59 lbs
    6-8 years
    4 tablets
    60-71 lbs
    9-10 years
    5 tablets
    72-95 lbs
    11 years
    6 tablets

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  • Other Information

    • Phenylketonurics: Contain Phenylalanine 14 mg per tablet
    • Do not use if imprinted safety seal under cap is broken or missing
    • Store at room temperature in a dry place
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  • Inactive Ingredients

    Aspartame, Colloidal Silica, D&C Red # 27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural & Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.

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  • Mapap Acetaminophen 80mg chw TAB
  • INGREDIENTS AND APPEARANCE
    CHILDRENS CHEWABLE MAPAP  
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68151-2262(NDC:0904-5256)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg
    Inactive Ingredients
    Ingredient Name Strength
    ASPARTAME (UNII: Z0H242BBR1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color pink Score no score
    Shape ROUND (ROUND BICONVEX TABLET) Size 10mm
    Flavor Imprint Code 1G
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68151-2262-4 1 in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 05/04/2011
    Labeler - Carilion Materials Management (079239644)
    Registrant - Carilion Materials Management (079239644)
    Establishment
    Name Address ID/FEI Business Operations
    Carilion Materials Management 079239644 REPACK(68151-2262)
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