MAPAP (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]

MAPAP (ACETAMINOPHEN) TABLET [MAJOR PHARMACEUTICALS]
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NDC 0904-1982-51, 0904-1982-59, 0904-1982-60, 0904-1982-61, 0904-1982-80
Set ID 9909dcd1-116d-4ed7-b9a6-ff2074e32f64
Generic Name
Product Class
Product Number
Application Number PART343
  • 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)

    AGEDOSE
    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 yearsask 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 TypeHUMAN OTC DRUGItem Code (Source)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, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (flat faced beveled edge) Size10mm
    FlavorImprint Code GPI;A325
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-1982-591 in 1 BOX04/21/201103/31/2021
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0904-1982-61100 in 1 CARTON04/21/201110/31/2019
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0904-1982-5150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/201106/30/2021
    4NDC:0904-1982-60100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/201107/31/2021
    5NDC:0904-1982-801000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/201109/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/21/201109/30/2021
    Labeler - Major Pharmaceuticals (191427277)