Label: IBUPROFEN tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 22, 2024

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  • Active ingredient (in each white tablet)

    Ibuprofen USP, 200 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

    ▪
    temporarily relieves minor aches and pains due to:
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    backache
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    menstrual cramps
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    toothache
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    muscular aches
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    headache
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    the common cold
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    minor pain of arthritis
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    temporarily reduces fever
  • Warnings

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

    ▪
    rash
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    hives
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    shock
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    facial swelling
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    asthma (wheezing)
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    blisters
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    skin reddening

    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

    ▪
    take more or for a longer time than directed
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    take a blood thinning (anticoagulant) or steroid drug
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    have had stomach ulcers or bleeding problems
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    have 3 or more alcoholic drinks every day while using this product
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    take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    ▪
    are age 60 or older

    Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

    Do not use

    ▪
    if you have ever had an allergic reaction to any other pain reliever/fever reducer
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    right before or after heart surgery

    Ask a doctor before use if

    ▪
    stomach bleeding warning applies to you
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    you have a history of stomach problems, such as heartburn
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    you are taking a diuretic
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    you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
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    you are taking a diuretic
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    you have problems or serious side effects from taking pain relievers or fever reducers

    Ask a doctor or pharmacist before use if you are

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

    When using this product

    ▪
    take with food or milk if stomach upset occurs

    Stop use and ask a doctor if

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    you experience any of the following signs of stomach bleeding:
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    feel faint
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    have bloody or black stools
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    vomit blood
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    have stomach pain that does not get better
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    you have symptoms of heart problems or stroke:
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    chest pain
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    slurred speech
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    leg swelling
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    trouble breathing
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    weakness in one part or side of body
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    pain gets worse or lasts more than 10 days
    ▪
    fever gets worse or lasts more than 3 days
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    redness or swelling is present in the painful area
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    any new symptoms appear

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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
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    the smallest effective dose should be used
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    adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
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    if pain or fever does not respond to 1 tablet, 2 tablets may be used
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    do not exceed 6 tablets in 24 hours, unless directed by a doctor
    ▪
    children under 12 years: ask a doctor
  • Other information

    ▪
    store between 20°-25°C (68°-77°F)
    ▪
    TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    ▪
    avoid excessive heat 40°C (104°F)
  • Inactive ingredients

    colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin

  • Questions or comments?

    Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

  • Generic Section

    Distributed by:

    MAJOR® PHARMACEUTICALS

    Indianapolis, IN 46268

    (800) 616-2471

    www.majorphaarmaceuticals.com

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L3432333-11024 / L3432333-21024

    50844

    REV1221043812

    Rev. 03/23

    M-17

    Re-order No. 301559
  • Principal Display Panel

    IBUPROFEN TABLETS, USP 200 mg

    Pain Reliever/Fever Reducer (NSAID)

    10 TABLETS

    200mg bag label
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-0669(NDC:0904-7914)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;438
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-0669-010 in 1 BAG06/03/2011
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07513906/03/2011
    Labeler - Cardinal Health 107, LLC (118546603)
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