Label: IBUPROFEN- ibuprofen tablet, film coated

  • NDC Code(s): 33992-0291-0, 33992-0291-2, 33992-0291-5
  • Packager: GREENBRIER INTERNATIONAL, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 5, 2017

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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
      • backache
      • menstrual cramps
      • 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
    • shock
    • facial swelling
    • rash
    • blisters
    • skin reddening
    • asthma (wheezing)

    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 had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • are age 60 or older
    • 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 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 have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • 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
    • have bloody or black stools
    • vomit blood
    • 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 (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 20º-25ºC (68º-77ºF)
    • avoid excessive heat 40ºC (104ºF)
    • see end flap for expiration date and lot number
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  • 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

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  • Questions or comments?

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

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  • Principal Display Panel

    ASSURED™

    COMPARE TO ACTIVE INGREDIENT OF
    ADVIL® TABLETS

    Ibuprofen

    • Ibuprofen Tablets USP, 200 mg
    Pain reliever / Fever reducer (NSAID)

    Actual Size

    100 tablets

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

    This product is not manufactured or distributed by Pfizer
    Consumer Healthcare, owner of the registered trademark Advil®
    Tablets.    50844           REV1116B29112

    DISTRIBUTED BY
    GREENBRIER INTERNATIONAL, INC.
    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

     

    Assured 44-291

    Assured 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:33992-0291
    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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    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:33992-0291-2 1 in 1 CARTON 05/24/1988
    1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:33992-0291-0 1 in 1 CARTON 05/24/1988
    2 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3 NDC:33992-0291-5 1 in 1 CARTON 05/24/1988
    3 50 in 1 BOTTLE, PLASTIC; 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 - GREENBRIER INTERNATIONAL, INC. (610322518)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(33992-0291)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(33992-0291)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(33992-0291)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(33992-0291)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(33992-0291)
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