Label: IBUPROFEN- ibuprofen tablet 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/14

If you are a consumer or patient please visit this version.

  • Active ingredient (in each brown tablet)

    Ibuprofen USP, 200 mg (NSAID)*

    *nonsteroifal 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
      • the common cold
      • toothache
      • muscular aches
      • backaches
      • minor pain of arthritis
      • menstrual cramps
    • 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)
    • skin reddening
    • shock
    • rash
    • blisers

    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 is you:

    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • are age 60 or older
    • take other drug containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • take more or for a longer time than directed
    • have 3 or more alcoholic drinks every day while using this product

    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 have asthma
    • 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, or kidney disease
    • 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

    •  you experience any of the following signs of stomach bleeding:
      • feel faint
      • have bloody or black stools
      • vomit blood
      • 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
    • 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.

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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 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, 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 8:30 am-4:00 pm ET, Monday-Friday

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  • Principal Display Panel

    ASSURED™

    COMPARED TO ACTIVE INGREDIENT OF ADVIL® TABLETS

    IBUPROFEN
    • Ibuprofen Tablets USP, 200 mg

    Pain reliever / Fever reducer (NSAID)

    100 tablets

    †This product is  manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Tablets.
    50844    REV0112A29112

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

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

    Assured 44-291

    Assured 44-291

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  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:33992-0291
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    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
    1 100 in 1 BOTTLE, PLASTIC
    2 NDC:33992-0291-0 1 in 1 CARTON
    2 40 in 1 BOTTLE, PLASTIC
    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)
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