Label: IBUPROFEN tablet, sugar coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 3, 2009

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

  • Active ingredient (in each tablet)

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

  • Purpose

    Pain Reliever / Fever Reducer

  • Uses

    Temporarily relieves minor aches and pains due to:

    • headache
    • the common cold
    • toothache
    • muscular aches
    • backache
    • minor pain of arthritis
    • menstrual cramps
    • 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 a nonsteroidal anti-inflammatory drug (NSAID) which may cause 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 an NSAID (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

    • problems or serious side effects from taking pain relievers or fever reducers
    • stomach problems that last or come back, such as heartburn, upset stomach or stomach pain
    • ulcers
    • bleeding problems
    • high blood pressure
    • reached age 60 or older
    • heart or kidney disease
    • taken a diuretic
    • asthma

    Ask a doctor or pharmacist before use if you are

    • taking any other drug containing an NSAID (prescription or nonprescription)
    • taking a blood thinning (anticoagulant) or steroid drug
    • under a doctor's care for any serious condition
    • taking aspirin to prevent 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
    • long term continuous use may increase the risk of heart attack or stroke

    Stop use and ask a doctor if

    • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
    • pain gets worse or lasts more than 10 days
    • stomach pain or upset gets worse or lasts
    • 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
    • do not take longer than 10 days unless directed by a doctor (see warnings)
    • adults and children 12 years of age and older: 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

    • read all warnings and directions before use. Keep carton
    • store at 20°-25°C (68°-77°F)
    • avoid excessive heat above 40°C (104°F)
  • Inactive ingredients

    acacia, calcium carbonate, carnauba wax, confectioner's sugar,crospovidone, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, kaolin, pharmaceutical ink, polyethylene glycol, powdered cellulose, pregelatinized starch, silicon dioxide, sodium benzoate, starch, sucrose, talc, titanium dioxide, white wax

  • PACKAGE DISPLAY PANEL

    Ibuprofen 200mg UD750 Label

    LABEL TEXT

    NDC 63739-134-01

    UD 750 Tablets (25X30)

    Mfg. By: Ohm Laboratories, Inc. 14 Terminal Road New Brunswick, NJ 08901

    Dist. By: McKesson Packaging 7101 Weddington Rd Concord, NC 28027

    LS-134-01-M08-01-A-R2

    FOR INSTITUTIONAL USE ONLY See window at back of box for expiration date and lot number.

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, sugar coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63739-134(NDC:51660-420)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 420
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63739-134-0130 in 1 BOX, UNIT-DOSE
    125 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07116301/10/2005
    Labeler - McKesson Packaging Services Business Unit of McKesson Corporation (140529962)