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Ibuprofen (Chain Drug Consortium LLC)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 1 BOTTLE in 1 CARTON (68016-295-01) > 100 TABLET, FILM COATED in 1 BOTTLE Label Information
TABLET, FILM COATED 1 BOTTLE in 1 CARTON (68016-295-50) > 50 TABLET, FILM COATED in 1 BOTTLE Label Information

Complete Ibuprofen Information

  • ACTIVE INGREDIENT(S)

    Ibuprofen 200 mg (NSAID)*

    ·        nonsteroidal anti-inflammatory drug


  • PURPOSE

    Pain reliever / fever reducer


  • USE(S)


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

  • WARNINGS

    Allergy alerts: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.

    Symptoms may include: 

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

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

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have bad stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drug containing prescription NSAID (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • the more or for a longer time than directed

  • DO NOT USE

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

  • ASK A DOCTOR BEFORE USE IF

     you have

    • problems or serious side effects from taking pain relievers or fever reducers
    • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
    • ulcers
    • bleeding problems
    • high blood pressure
    • heart or kidney disease
    • taken a diuretics
    • reached age 60 or older

  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF

    you are

    • taking any other drugs containg an NSAID (prescription or nonprescription)
    • taking a blood thining (anticoagulant) or steriod drug
    • under a doctor’s care for any serious condition
    • taking aspirin for heart attacks 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
    • long term continuous use may increase the risk of heart attack or stroke

  • STOP USE AND ASK DOCTOR IF

    • you feel faint, vomit blood, or have bloody or black stools.

            These are signs of stomach bleeding.

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • stomach pain or upset gets worse or lasts
    • redness or swelling is present in painful area
    • any new symptoms appear

  • PREGNANCY/BREASTFEEDING

    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 a 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 PoisonControlCenter 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 older
    • 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, unless directed by a doctor.
    Children under 12 years
    • ask a doctor

  • INACTIVE INGREDIENT(S)

    Colloidal silicon dioxide, Croscarmellose Sodium, Magnesium stearate, Microcrystalline sodium, Pregelatinised starch, talc.


  • STORAGE

    • store between 20-25 0c (68-77 0 F).
    • do not use if seal under bottle cap imprinted with” SEALED for YOUR PROTECTION” is broken or missing.

  • PRINCIPAL DISPLAY PANEL

    Carton Label PDP

    NDC# 68016-295-01

    DYE FREE
    Ibuprofen Tablets 200 mg

    PAIN RELIEVER/FEVER REDUCER (NSAID)

    SEE NEW WARNINGS INFORMATION

    100 COATED TABLETS

    Carton label - 100 count



    Bottle Label PDP

    NDC# 68016-295-01

    DYE FREE
    Ibuprofen Tablets 200 mg

    PAIN RELIEVER/FEVER REDUCER (NSAID)

    SEE NEW WARNINGS INFORMATION

    100 COATED TABLETS


    bottle-label-100ct


    Carton Label PDP

    NDC# 68016-295-50

    DYE FREE
    Ibuprofen Tablets 200 mg

    PAIN RELIEVER/FEVER REDUCER (NSAID)

    SEE NEW WARNINGS INFORMATION

    50 COATED TABLETS

    carton label-50 ct



    Bottle Label PDP

    NDC# 68016-295-50

    DYE FREE
    Ibuprofen Tablets 200 mg

    PAIN RELIEVER/FEVER REDUCER (NSAID)

    SEE NEW WARNINGS INFORMATION

    50 COATED TABLETS


    bottle-label-50 ct





  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-295
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 115
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68016-295-01 1 in 1 CARTON
    1 100 in 1 BOTTLE
    2 NDC:68016-295-50 1 in 1 CARTON
    2 50 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091237 05/07/2013
    Labeler - Chain Drug Consortium LLC (101668460)
    Registrant - Chain Drug Consortium LLC (101668460)
    Establishment
    Name Address ID/FEI Business Operations
    Marksans Pharma Limited 925822975 MANUFACTURE(68016-295)