EXTRA STRENGTH MAPAP (ACETAMINOPHEN) TABLET [MEDSOURCE PHARMACEUTICALS]

EXTRA STRENGTH MAPAP (ACETAMINOPHEN) TABLET [MEDSOURCE PHARMACEUTICALS]
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NDC 45865-656-20, 45865-656-30
Set ID 72053f9e-cca7-7e8a-e053-2995a90a99f0
Category HUMAN OTC DRUG LABEL
Packager Medsource Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART343
  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

  • Purposes

    Pain Reliever/Fever Reducer

    Aspirin Free Extra Strength Pain Reliever

  • 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.

    The maximum daily dose of this product is 6 tablets (3,000mg) in 24 hours.  Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen 
    • 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 you have

    liver disease.

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • 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

    This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In the 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 the directed (see overdose warning)

    Adults and children 12 years and over:

    • Take 2 tablets every 6 hours while symptoms last.
    • Do not take more than 6 tablets in 24 hours unless directed by a doctor
    • Do not take for more than 10 days unless directed by a doctor

    Children under 12 years: Do not use adult Extra Strength product in children under 12 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

  • PRINCIPAL DISPLAY PANEL - 20 count

    pdp

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH MAPAP 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45865-656(NDC:0904-1988)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUND (round flat faced beveled edge) Size12mm
    FlavorImprint Code GPI;A5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45865-656-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2018
    2NDC:45865-656-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34305/04/2011
    Labeler - Medsource Pharmaceuticals (833685915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medsource Pharmaceuticals833685915repack(45865-656)

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