IBUPROFEN TABLET, FILM COATED [CVS PHARMACY]

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IBUPROFEN TABLET, FILM COATED [CVS PHARMACY]
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NDC 59779-291-03, 59779-291-05, 59779-291-12, 59779-291-15, 59779-291-29, 59779-291-90, 59779-291-96, 59779-291-98
Set ID 8d9f11a5-ca98-4280-9c6a-093d32e60ace
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number ANDA075010
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  • Active ingredient (in each brown tablet)

    Ibuprofen USP,
    200 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

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

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

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

    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

    • have 3 or more alcoholic drinks every day while using this product
    • are age 60 or older
    • 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
    • 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 any other pain reliever/fever reducer 
    • right before or after heart surgery

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you are taking a diuretic
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
    • you have problems or serious side effects from taking pain relievers or fever reducers

    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

    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
    • leg swelling
    • slurred speech
    • weakness in one part or side of body
    • 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.

  • 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
  • Other information

    • store between 20º-25ºC (68º-77ºF)
    • avoid excessive heat 40ºC (104ºF)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

  • Questions or comments?

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

  • Principal Display Panel

    ♥︎CVS Health™

    Compare to the active
    ingredient in Advil® Tablets†

    Coated Tablets

    Ibuprofen
    IBUPROFEN TABLETS USP, 200 mg

    Pain reliever,
    Fever reducer (NSAID)

    20 COATED TABLETS
    (2 vials - 10 TABLETS EACH)

    Actual Size

    TAMPER EVIDENT: Use Only if This Blister is Intact

    †This product is not manufactured or distributed by Wyeth LLC, owner of the registered trademark Advil® Tablets.

    50844           REV0618C29103

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2019 CVS/pharmacy   
    CVS.com®    1-800-SHOP CVS    V-11112

    44-291

    44-291

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-291
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;291
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-291-982 in 1 PACKAGE05/24/1988
    110 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59779-291-101 in 1 PACKAGE05/24/1988
    210 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59779-291-121 in 1 CARTON05/24/1988
    3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:59779-291-962 in 1 PACKAGE05/24/1988
    4400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:59779-291-901 in 1 CARTON05/24/1988
    5120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:59779-291-151 in 1 CARTON05/24/1988
    650 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:59779-291-291 in 1 CARTON05/24/198812/03/2020
    7150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    8NDC:59779-291-0310 in 1 VIAL; Type 0: Not a Combination Product05/24/198812/03/2020
    9NDC:59779-291-05400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/198808/26/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07501005/24/1988
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(59779-291)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(59779-291)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(59779-291)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(59779-291)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(59779-291)
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