Label: MAPAP- acetaminophen tablet

  • Category: HUMAN OTC DRUG LABEL

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 September 25, 2017

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  • Active ingredient (in each tablet)

    Acetaminophen 325 mg

  • Purposes

    Pain reliever/fever reducer

    Aspirin-Free Pain Reliever/ Fever Reducer

  • 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.

  • 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 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.

  • 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.

  • Other information

    Store at room temperature
  • Inactive ingredients

    Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

  • Questions or comments?

    Adverse Drug Event call (800) 616-2471

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

    LHC54731216

    Distributed by:

    MAJOR® PHARMACEUTICALS

    17177 N Laurel Park Dr., Suite 233

    Livonia, MI 48152 USA

  • HOW SUPPLIED

    Product: 50090-0266

    NDC: 50090-0266-3 30 TABLET in a BOTTLE

    NDC: 50090-0266-1 15 TABLET in a BOTTLE

  • ACETAMINOPHEN

    Label Image
  • INGREDIENTS AND APPEARANCE
    MAPAP 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0266(NDC:0904-1982)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K12 (UNII: 333AG72FWJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUND (round flat faced beveled edge) Size10mm
    FlavorImprint Code GPI;A325
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-0266-3 30 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    2NDC:50090-0266-1 15 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201412/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/21/2011
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0266) , REPACK(50090-0266)