Label: IBUPROFEN tablet, film coated

  • 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 February 8, 2012

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  • Active ingredient(s)

    Ibuprofen USP, 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Use(s)

    • temporarily relieves minor aches and pains due to:

    • headache

    • toothache

    • backache

    • menstrual cramps

    • the common cold

    • muscular aches

    • minor pain of arthritis

    • temporarily reduces fever

  • Warnings

    Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    • hives

    • facial swelling

    • asthma (wheezing)

    • shock

    • skin reddening

    • rash

    • blisters

    If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • have had stomach ulcers or bleeding problems

    • take a blood thinning (anticoagulant) or steroid drug

    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

    • have 3 or more alcoholic drinks every day while using this product

    • take more or for a longer time than directed

    Do not use

    • right before or after heart surgery

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer

    Ask a doctor before use if you have

    • stomach bleeding warning applies to you

    • you have a history of stomach problems, such as heartburn

    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

    • you are taking a diuretic

    • you have asthma

    • you have problems or serious side effects from taking pain relievers or fever reducers

    Ask a doctor or pharmacist before use if you are

    • taking any other drug
    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • under a doctor"s care for any serious condition

    When using this product

    • take with food or milk if stomach upset occurs

    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:

    • feel faint

    • have bloody or black stools

    • vomit blood

    • have stomach pain that does not get better

    • pain gets worse or lasts more than 10 days

    • fever gets worse or lasts more than 3 days

    • redness or swelling is present in the painful area

    • any new symptoms appear

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • do not take more than directed

    • the smallest effective dose should be used

    • do not take longer than 10 days, unless directed by a doctor (see Warnings)

    • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist

    • if pain or fever does not respond to 1 tablet, 2 tablets may be used

    • do not exceed 6 tablets in 24 hours,

    • children under 12 years: ask a doctor

  • Other information

    • store between 20°-25°C (68°-77°F)

    • avoid excessive heat 40°C (104°F)

    • use by expiration date on package

  • Inactive ingredients

    carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

  • Questions?

    To Report Adverse Drug Event Call: (800) 616-2471

  • Principal Display Panel

    The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

    MAJOR®

    NDC 0904-7915-80

    †Compare to the active ingredient in Advil® Tablets

    See New Warnings Information

    Ibuprofen

    Tablets

    Ibuprofen Tablets, USP 200 mg

    Pain Reliever

    Fever Reducer (NSAID)

    1000 COATED TABLETS

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAD UNDER CAP IS BROKEN OR MISSING

    50844        REV0910B29116

    Distributed by

    MAJOR PHARMACEUTICALS

    31778 Enterprise Drive

    Livonia, MI 48150 USA      M-17        Rev.11/10

    Re-order No. 700643


    Repacked by:

    H.J. Harkins Company, Inc.

    Nipomo, CA 93444
    Product Packaging

    Product Packaging

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-187(NDC:0904-7915)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;291
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52959-187-00100 in 1 BOTTLE, PLASTIC
    2NDC:52959-187-02120 in 1 BOTTLE, PLASTIC
    3NDC:52959-187-03200 in 1 BOTTLE, PLASTIC
    4NDC:52959-187-1010 in 1 BOTTLE, PLASTIC
    5NDC:52959-187-1515 in 1 BOTTLE, PLASTIC
    6NDC:52959-187-2020 in 1 BOTTLE, PLASTIC
    7NDC:52959-187-2121 in 1 BOTTLE, PLASTIC
    8NDC:52959-187-2424 in 1 BOTTLE, PLASTIC
    9NDC:52959-187-2525 in 1 BOTTLE, PLASTIC
    10NDC:52959-187-3030 in 1 BOTTLE, PLASTIC
    11NDC:52959-187-4040 in 1 BOTTLE, PLASTIC
    12NDC:52959-187-5050 in 1 BOTTLE, PLASTIC
    13NDC:52959-187-6060 in 1 BOTTLE, PLASTIC
    14NDC:52959-187-9090 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34305/24/1988
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Registrant - H.J. Harkins Company, Inc. (147681894)
    Establishment
    NameAddressID/FEIBusiness Operations
    H.J. Harkins Company, Inc.147681894repack, relabel
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