IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP]

IBUPROFEN TABLET, FILM COATED [GERI-CARE PHARMACEUTICAL CORP]
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NDC 57896-941-01, 57896-941-05, 57896-941-10, 57896-941-20, 57896-941-25, 57896-941-50
Set ID 0744c3ca-4224-4f6a-a033-880949b544fd
Category HUMAN OTC DRUG LABEL
Packager Geri-Care Pharmaceutical Corp
Generic Name
Product Class
Product Number
Application Number ANDA075010
  • Active ingredient (in each brown 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
    • toothache
    • backache
    • menstrual cramps
    • the common cold
    • muscular aches
    • minor pain of arthritis
    • Temporarily reduces fever
  • 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
      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

    • 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

    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
    • 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
    • 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 (1-800-222-1222) right away.

  • Directions

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

    • store between 20°-25°C (68°-77°F)
    • avoid excessive heat 40°C (104°F)
  • Inactive ingredients

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

    Questions or comments?

    Call 1-800-540-3765

  • Package label

    1

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-941
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (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
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44291
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-941-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2017
    2NDC:57896-941-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2017
    3NDC:57896-941-0550 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2017
    4NDC:57896-941-25250 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2017
    5NDC:57896-941-50500 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2017
    6NDC:57896-941-201 in 1 CARTON02/01/2012
    6200 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07501001/01/2004
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)