MAPAP (ACETAMINOPHEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]

MAPAP (ACETAMINOPHEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]
PDF | XML

NDC 49999-131-30, 49999-131-60, 49999-131-90
Set ID 51c44fdf-9b6f-4ded-b755-d18a7d2dd4dc
Category HUMAN OTC DRUG LABEL
Packager Lake Erie Medical DBA Quality Care Products LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • Active Ingredients (in each tablet)

    Acetaminophen 325 mg

  • Purposes

    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 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.

  • Directions

    Do not take more than directed
    AGEDOSE
    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?

    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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MAPAP 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49999-131(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 (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    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:49999-131-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/2011
    2NDC:49999-131-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/201106/01/2014
    3NDC:49999-131-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/201106/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/21/2011
    Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lake Erie Medical DBA Quality Care Products LLC831276758repack(49999-131)