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kirkland signature ibuprofen ib (Costco Wholesale Company)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 750 TABLET, FILM COATED in 1 BOTTLE (63981-517-59) Label Information

Complete kirkland signature ibuprofen ib Information

  • Active ingredient (in each caplet)

    Ibuprofen 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug


  • Purposes

    Pain reliever/fever reducer


  • Uses

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

  • 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 severe stomach bleeding. The chances are 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 prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed
     
    • 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 ibuprofen or 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
    • the stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
    • you are taking a diuretic

    Ask a doctor or pharmacist before use if you are
    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • under a doctor’s care for any serious condition
    • taking any other drug

    When using this product
    • take with food or milk if stomach upset occurs

    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
    • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear

    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.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


  • Directions

    • do not take more than directed
    • the smallest effective dose should be used

    adults and children 12 years and older

    • take 1 caplet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 caplet, 2 caplets may be used
    • do not exceed 6 caplets in 24 hours, unless directed by a doctor

    children under 12 years

    • ask a doctor

  • Other information

    • read all warnings and directions before use
    • store at 20-25°C (68-77°F)
    • avoid high humidity and excessive heat above 40°C (104°F)

  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide


  • Questions or comments?

    1-800-719-9260


  • Principal Display Panel

    COMPARE TO MOTRIN® IB active ingredient

    See New Warnings

    IBUPROFEN IB TABLETS

    Ibuprofen Tablets USP, 200 mg

    Pain Reliever/Fever Reducer (NSAID)

    DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

    Actual Size

    500 CAPLETS†

    †Capsule-Shaped Tablets

    517-5n-ibuprofen-ib-tablets.jpg
    517-5n-ibuprofen-ib-tablets-2.jpg

  • INGREDIENTS AND APPEARANCE
    KIRKLAND SIGNATURE IBUPROFEN IB 
    ibuprofen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-517
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color ORANGE Score no score
    Shape OVAL Size 14mm
    Flavor Imprint Code I2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63981-517-59 750 in 1 BOTTLE; Type 0: Not a Combination Product 06/22/2007 09/11/2016
    2 NDC:63981-517-90 2 in 1 PACKAGE 12/11/2014
    2 500 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077349 06/22/2007
    Labeler - Costco Wholesale Company (103391843)