Label: IBUPROFEN - ibuprofen tablet, film coated

  • NDC Code(s): 57896-941-01, 57896-941-05, 57896-941-10, 57896-941-25, view more
    57896-941-50
  • Packager: Geri-Care Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 01/13

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

  • Active ingredient (in each brown tablet)

    Ibuprofen USP, 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

    Close
  • Purpose

    Pain reliever/fever reducer

    Close
  • 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
    Close
  • Warnings

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

    • shock
    • hives
    • facial swelling
    • asthma (wheezing)
    • 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

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

    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 -vomit blood -have bloody or black stools -have stomach pain that does not get better
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present in the painful area
    • fever gets worse or lasts more than 3 days
    • any new symptoms occur
    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.

    Close
  • Directions

    • do not use 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 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 take more than 6 tablets in 24 hours unless directed by a doctor
    • children under 12 years: ask a doctor
    Close
  • Other information

    • store at controlled room temperature
    • avoid excessive heat 40°C (104°F)
    Close
  • Inactive ingredients

    carnauba wax, cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, PEG, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide.

    Questions or comments?

    Call 1-800-540-3765

    Close
  • Package label

    GERICARE
    NDC 57896-941-01
    SEE NEW WARNINGS
    IBUPROFEN
    pain reliever/fever reducer (NSAID)
    COMPARE TO THE ACTIVE INGREDIENT IN ADVIL*
    100 Tablets
    200 mg each
    Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
    Ibuprofen label

    Close
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  
    ibuprofen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-941
    Route of Administration ORAL DEA Schedule     
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color brown Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 44291
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57896-941-01 100 in 1 BOTTLE
    2 NDC:57896-941-10 1000 in 1 BOTTLE
    3 NDC:57896-941-05 50 in 1 BOTTLE
    4 NDC:57896-941-25 250 in 1 BOTTLE
    5 NDC:57896-941-50 500 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075010 01/01/2004
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
    Establishment
    Name Address ID/FEI Business Operations
    Geri-Care Pharmaceutical Corp 611196254 repack(57896-941)
    Close