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

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 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 LABEL Item Code (Source) NDC:57896-941
    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
    CARNAUBA WAX  
    STARCH, CORN  
    SILICON DIOXIDE  
    HYPROMELLOSES  
    LACTOSE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    FERRIC OXIDE RED  
    STEARIC ACID  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    TITANIUM DIOXIDE  
    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