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Mapap (Major Pharmaceuticals)

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TABLET 100 TABLET in 1 BLISTER PACK (0904-1982-61) Label Information

Complete Mapap Information

  • 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


  • Principal Display Panel Unit Dose Label

    MAJOR® PHARMACEUTICALS

    NDC 0904-1982-61

    Unit Dose

    See New Warnings Information

    MAPAP TABLETS

    (Regular Strength Acetaminophen)

    325 mg 100 TABLETS

    carton label

  • Principal Display Panel

    MAJOR®

    NDC 0904-1982-80

    THIS LARGE SIZE PACKAGE FOR DISPENSING PURPOSE ONLY

    Compare to the active ingredient in regular strength Tylenol® Tablets*

    Mapap

    Regular Strength

    TABLETS

    Aspirin-Free Pain Reliever/Fever Reducer

    See New Warnings Information

    1000 ACETAMINOPHEN TABLETS

    325 mg. EACH

    *This product is not manufactured or distributed by Mcneil Consumer Products Co. owner of the registered trademark Tylenol®.

    bottle label

  • INGREDIENTS AND APPEARANCE
    MAPAP 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) 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 K12 (UNII: 333AG72FWJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    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:0904-1982-59 1 in 1 BOX 04/21/2011
    1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:0904-1982-61 100 in 1 CARTON 04/21/2011
    2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:0904-1982-51 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/21/2011
    4 NDC:0904-1982-60 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/21/2011
    5 NDC:0904-1982-80 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/21/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/21/2011
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - GEMINI PHARMACEUTICALS INC. (055942270)
    Establishment
    Name Address ID/FEI Business Operations
    GEMINI PHARMACEUTICALS INC. 055942270 MANUFACTURE(0904-1982)