Label: IBUPROFEN - ibuprofen tablet

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

Drug Label Information

Updated 03/13

If you are a consumer or patient please visit this version.

  • Active Ingredient (In each tablet)

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

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  • Purpose

    Pain reliever/ fever reducer

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  • Uses

    temporarily relieves minor aches and pain due to

    • minor pain of arthritis
    • headache
    • toothache
    • backache
    • the common cold
    • menstrual cramps
    • muscular aches

    temporarily reduces fever

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  • 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 stomach bleeding. The chance is higher if you

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others]
    • have 3 or more alcoholic drinks everyday while using this product
    • take more or for a longer time than directed
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  • Do not use

    • if you have ever had an allergic reaction to any other pain reliever/ fever reducer
    • right before or after heart surgery
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  • Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have problems or serious side effects from taking pain relievers or fever reducers
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
    • you are taking a diuretic
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  • Ask a doctor or pharmacist before use if you are

    • under a doctor's care for any serious condition
    • taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • taking any other drug
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  • 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
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  • stop use and ask a doctor if

    you experience any of the following signs of stomach bleeding

    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • pain gets worse or last for more than 10 days
    • fever gets worse or last more than 3 days
    • redness or swelling is present in the painful area

    any new symptoms appear

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  • 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.

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  • keep out of reach of children

    In case of overdose, get medical help or contact a poison control center right away.

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  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    Adults and children 12 years and older
    • take one tablet every 4 to 6 hours while symptoms persists
    • If pain or fever does not respond to 1 tablet, 2 tablets may be used
    • do not exceed 6 tablets in 24 hours, unless directed by a doctor
    Children under 12 years
    • ask a doctor
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  • Other Information

    • store between 20o- 25oC (68o- 77oF)
    • avoid high humidity and excessive heat above 40oC (104oF)
    • Tamper Evident: do not use if the imprinted seal under the cap is broken or missing
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  • Inactive Ingredients:

    colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, FD&C yellow #6 Al. lake, sodium starch glycolate, talc, titanium dioxide and triacetin.

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  • Questions? Adverse drug event call: (866) 562-2756
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-018
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TRIACETIN (UNII: XHX3C3X673)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color orange Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code IBU200
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61715-018-50 1 in 1 CARTON
    1 50 in 1 BOTTLE, PLASTIC
    2 NDC:61715-018-51 1 in 1 CARTON
    2 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091355 11/22/2011
    Labeler - Kinray (012574513)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    Name Address ID/FEI Business Operations
    Pharbest Pharmaceuticals, Inc. 557054835 repack(61715-018) , relabel(61715-018)
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