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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

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Acetaminophen 325 mg


  • PURPOSE

    Purposes

    Pain reliever/fever reducer


  • INDICATIONS & USAGE

    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

    Warnings

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

    • adult takes more than 4,000 mg in 24 hours
    • child takes more than 5 doses in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks every day while using this product

    Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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
    • 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: 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.


  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than directed (see overdose warning)

    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 10 tablets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
    Children 6 years to under 12 years
    • take 1 tablet every 4 to 6 hours while symptoms last
    • do not take more than 5 tablets in 24 hours
    • do not use for more than 5 days unless directed by a doctor
    Children under 6 years ask a doctor


  • STORAGE AND HANDLING

    Other information

    • Store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients

    Povidone, pregelatinized starch, sodium starch glycolate, stearic acid


  • QUESTIONS

    Questions or comments?Call (800) 616-2471


  • OTHER SAFETY INFORMATION

    Do not use if imprinted Safety Seal under cap is broken or missing


  • SPL UNCLASSIFIED SECTION

    Distributed By: MAJOR® PHARMACEUTICALS

    17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA


  • PRINCIPAL DISPLAY PANEL

    MAJOR®

    NDC 0904-1982-60

    Mapap

    Regular Strength

    TABLETS

    Aspirin–Free Pain Reliever/Fever Reducer

    See New Warnings Information & Directions

    100 ACETAMINOPHEN TABLETS

    325 mg EACH

    Major 1982 - APAP 325 mg Tabs

    NDC 0904-1982-61

    Unit Dose

    0904-1982-61


  • 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, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color white Score no score
    Shape 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 07/31/2021
    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)