Label: MAPAP EXTRA STRENGTH- acetaminophen capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 August 8, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    (in each capsule)
    Acetaminophen 500 mg

  • Purposes

    Analgesic, Antipyretic

  • Uses

    • temporarily relieves minor aches and pains due to
    • the common cold
    • headache
    • toothache
    • muscular aches
    • backache
    • minor pain of arthritis
    • premenstrual and menstrual cramps
    • temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 8 capsules in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product
  • Do not use

    • with any other drugs 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 you have

    liver disease

  • Ask a doctor before use if you are

    taking the blood thinning drug warfarin

  • Stop use and ask a doctor if

    • new symptoms occur
    • redness or swelling is present
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts more than 3 days

    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 In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

     adults and children 12 years of age and over take 2 capsules every  4 hour to 6 hours, not to exceed 8 capsules in 24 hours. Do not take for more than 10 days unless directed by a doctor.  
     children under 12 years of age Do not use Extra Strength product in children 12 years of age; this will provide more than the recommended dose (overdose) of pain reliever and could cause liver damage.

    DO NOT EXCEED RECOMMENDED DOSE

    Other information

    • store at room temperature, USP
    • use by expiration date on pckage
    • do not use if capsule band or imprinted safety seal under cap is broken or missing
    • side effects occur
    • You may report side effects at 1-800-616-2471 (Toll Free)
  • Inactive Ingredients

    FD&C Blue #1, FD&C Red #40, Gelatin, Polyvinylpyrrolidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid and Titanium Dioxide.

    *Major Extra Strength Mapap is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.

    Distributed by:
    MAJOR PHARMACEUTICALS
    Livonia, MI 48150  USA

    This Product was Repackaged By:

    State of Florida DOH Central Pharmacy
    104-2 Hamilton Park Drive
    Tallahassee, FL 32304
    United States

    They are supplied by State of Florida DOH Central Pharmacy as follows:

    NDCStrengthQuantity/FormColorSource Prod. Code
    53808-0822-1500 mg30 Capsules in a Blister PackRED0904-1987
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Mapap Extra Strength Capsules

     

  • INGREDIENTS AND APPEARANCE
    MAPAP  EXTRA STRENGTH
    acetaminophen capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53808-0822(NDC:0904-1987)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code CPC;617
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53808-0822-130 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34301/01/2013
    Labeler - State of Florida DOH Central Pharmacy (829348114)
    Establishment
    NameAddressID/FEIBusiness Operations
    State of Florida DOH Central Pharmacy829348114repack(53808-0822)
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