Label: IBUPROFEN - ibuprofen tablet

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 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 LABEL Item Code (Source) NDC:61715-018
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    TITANIUM DIOXIDE  
    STARCH, CORN  
    TRIACETIN  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    TALC  
    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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