Label: MAPAP- acetaminophen tablet

  • 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 February 22, 2017

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

  • Active Ingredients (in each tablet)

    Acetaminophen 325 mg

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  • Purposes

    Pain reliever/fever reducer

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  • Uses

    for the temporary relief of minor aches and pains due to:

    • Headache
    • Muscular aches
    • Backache
    • Minor pain of arthritis
    • The common cold
    • Toothache
    • Premenstrual and menstrual cramps

    Temporarily reduces fever.

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  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if

    • adult takes more than 12 tablets in 24 hours,which is the maximum daily amount
    • child takes more than 5 doses in 24 hours
    • taken with other drugs containing acetaminophen 
    • adult has 3 or more alcoholic drinks every day while using this product

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if the user has liver disease

    Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    • Pain gets worse or lasts more than 10 days in adults and children
    • Pain gets worse or lasts more than 5 days in children under 12 years
    • Fever gets worse or lasts more than 3 days
    • New symptoms occur
    • Redness or swelling is present. 

    These could be signs of a serious condition

    If pregnant or breast-feeding, ask a health professional before use. 

    Keep out of reach of children.  Overdose warning:  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 for children even if you do not notice any signs or symptoms.

    Do not use

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

    Ask a doctor before use if the user has

    liver disease

    Ask a doctor or pharmacist before use if the user is

    taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • Pain gets worse or lasts more than 10 days in adults and children
    • Pain gets worse or lasts more than 5 days in children under 12 years
    • Fever gets worse or lasts more than 3 days
    • New symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning

    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 for children even if you do not notice any signs or symptoms.

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  • Directions

    Do not take more than directed
    AGE DOSE
    Adults and children 12 years and over
    • Take 2 tablets every 4 to 6 hours while symptoms last
    • Do not take more than 12 tablets in 24 hours
    Children 6 to 11 years
    • Take 1 tablet every 4 to 6 hours while symptoms last
    •  Do not take more than 5 tablets in 24 hours
    Children under 6 years  Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

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  • Other information

    • Store at room temperature
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  • Inactive Ingredients

    Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

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  • Questions?

    To Report Adverse Drug Event call (800) 616-2471 Dist. By MAJOR PHARMACEUTICALS 31778 Enterprise Drive. Livonia, MI  48150

    Tamper Evident:  Do not use if sealed blister units are broken or damaged.

    Reorder No. 251706

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  • Image of Label
  • INGREDIENTS AND APPEARANCE
    MAPAP 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49999-131(NDC:0904-1982)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND (round flat faced beveled edge) Size 10mm
    Flavor Imprint Code GPI;A325
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49999-131-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/21/2011
    2 NDC:49999-131-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/21/2011 06/01/2014
    3 NDC:49999-131-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/21/2011 06/01/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/21/2011
    Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
    Establishment
    Name Address ID/FEI Business Operations
    Lake Erie Medical DBA Quality Care Products LLC 831276758 repack(49999-131)
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