Label: IBUPROFEN- ibuprofen tablet, film coated

  • NDC Code(s): 59779-291-03, 59779-291-15, 59779-291-29
  • Packager: WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 01/15

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  • Active ingredient (in each brown tablet)

    Ibuprofen USP, 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 pains due to:

      • headache

      • toothache

      • menstrual cramps

      • backache

      • the common cold

      • muscular aches

      • minor pain of arthritis

    • 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 severe stomach bleeding. The chance is higher if you:

    • take a blood thinning (anticoagulant) or steroid drug

    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

    • have had stomach ulcers or bleeding problems

    • are age 60 or older

    • have 3 or more alcoholic drinks every day while using this product

    • take more or for a longer time than directed

    Do not use

    • right before or after heart surgery

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer

    Ask a doctor before use if

    • you are taking a diuretic

    • 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, or kidney disease

    • you have problems or serious side effects from taking pain relievers or fever reducers

    • you have asthma

    Ask a doctor or pharmacist before use if you are

    • under a doctor's care for any serious condition
    • taking aspirin for heart attack 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

    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:

      • feel faint

      • have bloody or black stools

      • vomit blood

      • have stomach pain that does not get better

    • pain gets worse or lasts more than 10 days

    • fever gets worse or lasts more than 3 days

    • any new symptoms appear

    • redness or swelling is present in the painful area

    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 (1-800-222-1222) 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 over: 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

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  • Other information

    • store between 20°-25°C (68°-77°F)

    • avoid excessive heat 40°C (104°F)

    • use by expiration date on package

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  • Inactive ingredients

    carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

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  • Questions or comments?

    Call 1-800-426-9391 8:30AM-4:00PM ET, Monday-Friday

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  • Principal Display Panel

    CVS
    pharmacy™                                                                  Compare to the active ingredient in Advil® Tablets†

                                          NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

    IBUPROFEN
    TABLETS
    IBUPROFEN TABLETS, 200mg

    Pain reliever/
    Fever reducer (NSAID)

    150 Coated Tablets                      Actual Size

    †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Tablets.
    50844    ORG011229129

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    ©2014 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS
    V-11112

    CVS Quality Money Back Guarantee

    CVS 44-291

    CVS 44-291

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  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-291
    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
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color BROWN Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 44;291
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-291-15 1 in 1 CARTON
    1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:59779-291-29 1 in 1 CARTON
    2 150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3 NDC:59779-291-03 10 in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075010 05/24/1988
    Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(59779-291)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(59779-291)
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