Label: MAPAP EXTRA STRENGTH- acetaminophen capsule

  • NDC Code(s): 0904-1987-60, 0904-1987-80
  • Packager: Major Pharmaceuticals
  • 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.

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Updated May 19, 2020

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  • Drug Facts

    Active Ingredient (in each banded capsule)

    Acetaminophen 500 mg

  • Purpose

    Purpose

    Pain reliever/ Fever reducer

  • Uses

    Temporarily reduces fever and relieves minor aches and pains due to:

    • headache
    • muscular aches
    • common cold
    • toothache
    • backache
    • minor pain of arthritis
    • premenstrual and menstrual cramps
  • Warnings

    Liver warning: This product contains acetaminophen. 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

    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 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 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 for 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.

    Overdose warning:

    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 directed (see overdose warning).

    adults and children 12 years and over:

    • take 2 capsules every 6 hours while symptoms last
    • Do not take more than 6 capsules 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: ask a doctor

  • Other information

    • store at room temperature
  • Inactive Ingredients

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

  • Questions?

    Call: (800) 616-2471

  • SPL UNCLASSIFIED SECTION

    Distributed by: Major® Pharmaceuticals

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

    Re-order No. 700691 Rev.05/19 M-29 4050-05-19

  • PRINCIPAL DISPLAY PANEL

    Major

    NDC 0904-1987-60

    EXTRA STRENGTH

    Mapap

    Acetaminophen 500 mg Each

    CAPSULES SAFETY SEALED FOR YOUR PROTECTION

    SEE NEW WARNINGS INFORMATION AND DIRECTIONS

    ASPIRIN FREE

    Strong Pain & Fever Relief

    100 CAPSULES

    0617-Major label

  • INGREDIENTS AND APPEARANCE
    MAPAP  EXTRA STRENGTH
    acetaminophen capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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
    Colorwhite, redScoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code CPC;617
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-1987-60100 in 1 BOTTLE; Type 0: Not a Combination Product12/22/1997
    2NDC:0904-1987-801000 in 1 BOTTLE; Type 0: Not a Combination Product01/29/200104/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/22/1997
    Labeler - Major Pharmaceuticals (191427277)
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