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IBUPROFEN (HART Health)

Available Formats

Dosage Form Package Information Links
TABLET 250 PACKET in 1 BOX, UNIT-DOSE (50332-0118-8) > 2 TABLET in 1 PACKET Label Information
TABLET 125 PACKET in 1 BOX, UNIT-DOSE (50332-0118-7) > 2 TABLET in 1 PACKET Label Information
TABLET 50 PACKET in 1 BOX, UNIT-DOSE (50332-0118-4) > 2 TABLET in 1 PACKET Label Information

Complete IBUPROFEN Information

  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet): Ibuprofen (NSAID)* 200mg (*nonsteroidal anti-inflammatory drug)


  • PURPOSE

    Purpose: Pain Reliever / Fever Reducer


  • INDICATIONS & USAGE

    Uses: Temporarily relieves minor aches and pains due to

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

    Temporarily reduces fever


  • WARNINGS

    Warnings:

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

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

    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 more or for a longer time than directed
    • take a blood thinning (anticoagulant) or steroid drug
    • have 3 or more alcoholic drinks every day while using this product
    • take other drugs containing prescription or non-prescriptin NSAIDs (aspirin, ibuprofen, naproxen, or others)


  • DO NOT USE

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or afte rheart surgery


  • ASK DOCTOR

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history orstomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking any other drug containing an NSAID
    • taking a blood thinning (anticoagulant) or steroid drug
    • taking aspirin for heart attach or stroke (ibuprofen may decrease the benefit if aspirin)
    • under a doctor's care for any serious condition


  • WHEN USING

    When using this product

    • take with food or milk if stomach upset occurs
    • long term continuous use may increase the risk of heart attack or stroke

  • STOP USE

    Stop use and ask a doctor if

    • an allergic reaction occurs, seek medical help right away
    • fever gets worse or lasts more than 3 days
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present in the painful area
    • new symptoms occur
    • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better

  • PREGNANCY OR BREAST FEEDING

    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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222


  • DOSAGE & ADMINISTRATION

    Directions: Do not take more than directed; the smallest effective dose should be used.

    Adults and children 12 years of age and over:

    • take 1 tablet every 4 hours while symptoms persist
    • if pain or fever does not respond to 1 tabet, 2 tablets may be used
    • do not take more than 6 tablets in 24 hours unless directed by a doctor

    Children under 12 years of age: ask a doctor


  • INACTIVE INGREDIENT

    Inactive Ingredients: Carnauba Wax, Croscarmellose Sodium, FD&C Blue #2 Lake, FD&C Red #40 Lake, FD&C Yellow #6 Lake, D&C Yellow #10 Lake, Hydroxypropyl Methylcellulose, Magnesiuum Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Red Iron Oxide, Silicon Dioxide, Titanium Dioxide


  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0118
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color brown 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:50332-0118-4 50 in 1 BOX, UNIT-DOSE
    1 2 in 1 PACKET
    2 NDC:50332-0118-7 125 in 1 BOX, UNIT-DOSE
    2 2 in 1 PACKET
    3 NDC:50332-0118-8 250 in 1 BOX, UNIT-DOSE
    3 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 06/03/1987
    Labeler - HART Health (069560969)