MAPAP (ACETAMINOPHEN) TABLET [ST. MARY'S MEDICAL PARK PHARMACY]

MAPAP (ACETAMINOPHEN) TABLET [ST. MARY'S MEDICAL PARK PHARMACY]
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NDC 60760-935-50
Set ID 5e98432a-652b-bab8-e053-2a91aa0afaa8
Category HUMAN OTC DRUG LABEL
Packager St. Mary's Medical Park Pharmacy
Generic Name
Product Class
Product Number
Application Number PART343
  • 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

    acet

  • INGREDIENTS AND APPEARANCE
    MAPAP 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60760-935(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:60760-935-5050 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/21/2011
    Labeler - St. Mary's Medical Park Pharmacy (063050751)
    Registrant - GEMINI PHARMACEUTICALS INC. (055942270)
    Establishment
    NameAddressID/FEIBusiness Operations
    GEMINI PHARMACEUTICALS INC.055942270manufacture(60760-935)
    Establishment
    NameAddressID/FEIBusiness Operations
    St. Mary's Medical Park Pharmacy063050751relabel(60760-935) , repack(60760-935)

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