MAPAP EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE [MAJOR PHARMACEUTICALS]

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MAPAP EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE [MAJOR PHARMACEUTICALS]
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NDC 0904-1987-60, 0904-1987-80
Set ID 34a95450-3f04-4de4-9113-73e7bd5724a0
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART343
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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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