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Ibuprofen (Wal-Mart Stores Inc)

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CAPSULE, COATED 2 BOTTLE in 1 CARTON (49035-393-12) > 100 CAPSULE, COATED in 1 BOTTLE Label Information

Complete Ibuprofen Information

  • Active ingredient (in each orange caplet)

     Ibuprofen USP, 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug


  • Purpose

    Pain reliever/fever reducer


  • 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 

  • 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:

    • 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

    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 a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • stomach bleeding warning applies to you
    • you are taking a diuretic
    • you have asthma
    • 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
    • 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
    • any new symptoms appear
    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • have stomach pain that does not get better
      • vomit blood
      • have bloody or black stools
    • 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

    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 complication 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.


  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • adults and children 12 years and over: 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

    • store between 20º-25ºC (68º-77ºF)
    • avoid excessive heat 40ºC (104ºF)
    • use by expiration date on package

  • Inactive ingredients

    carnauba wax, cellulose, corn starch, FD&C yellow #6 aluminum lake, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide


  • Questions or comments?

    1-888-287-1915


  • Principal Display Panel

    NDC 49035-393-12

    equateâ„¢

    Compare to Motrin® IB Caplets Active Ingredient†

    Ibuprofen
    Ibuprofen Tablets USP, 200 mg
    Pain Reliever/Fever Reducer
    (NSAID)

    **Capsule Shaped Tablets

    200 mg
    100 CAPLETS**    
       

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Satisfaction guaranteed - For questions or comments please call 1-888-287-1915.

    Distributed by: Wal-Mart Stores, Inc.,
    Bentonville, AR 72716
    †This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Motrin® IB Caplets.
    50844        REV0411A39312

    Equate 44-393

    Equate 44-393


  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-393
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color ORANGE Score no score
    Shape OVAL Size 14mm
    Flavor Imprint Code 44;393
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-393-12 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2002 07/08/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075139 04/08/2002 07/08/2019
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(49035-393)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(49035-393)