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Ibuprofen (NSAID) (Rebel Distributors Corp)

Available Formats

Dosage Form Package Information Links
TABLET 50 TABLET in 1 BOTTLE (21695-065-50) Label Information
TABLET 90 TABLET in 1 BOTTLE (21695-065-90) Label Information
TABLET 6 TABLET in 1 BOTTLE (21695-065-06) Label Information
TABLET 60 TABLET in 1 BOTTLE (21695-065-60) Label Information
TABLET 30 TABLET in 1 BOTTLE (21695-065-30) Label Information
TABLET 14 TABLET in 1 BOTTLE (21695-065-14) Label Information
TABLET 28 TABLET in 1 BOTTLE (21695-065-28) Label Information

Complete Ibuprofen (NSAID) Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    (in each tablet)

    Ibuprofen USP, 200 mg (NSAID)**

    **nonsteroidal anti-inflammatory drug


  • PURPOSE

    Pain reliever/fever reducer


  • Keep out of reach of children


  • USES

    • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • 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 severe stomach bleeding. The chances are 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

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

    Ask a doctor or pharmacist before use if you are

    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • under a doctor's care for any serious condition
    • taking any other drug
    • taking any other drug containing an NSAID (prescription or nonprescription)
    • taking a blood thinning (anticoagulant) or steroid 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 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
    • 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 (1-800-222-1222) right away.


  • DIRECTIONS

    • do not take more than directed
    • the smallest effective dose should be used
    Adults and children
    12 years 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

    • Store between 20 - 25°C (68 - 77°F)
    • Read all warnings and directions before use

  • INACTIVE INGREDIENTS

    • Brown Tablets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch Corn, Titanium Dioxide
    • Orange Tablets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, FD&C Yellow #6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch, Titanium Dioxide

       


  • Questions or Comments

    Call 1-877-835-5472

    Monday through Friday 9AM - 5PM EST.

    *Amneal Pharmaceuticals is not affiliated with the owner of the trademark Advil®


  • SPL UNCLASSIFIED SECTION

    Distributed By:

    Ameal Pharmaceuticals

    Glasgow, KY 42141

    Repackaged by:

    Rebel Distributors Corp

    Thousand Oaks, CA 91320


  • PRINCIPAL DISPLAY PANEL

    Ibuprofen 200mg


  • INGREDIENTS AND APPEARANCE
    IBUPROFEN (NSAID)  PAIN RELEIVER/ FEVER REDUCER
    ibuprofen (nsaid) tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-065(NDC:53746-140)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BROWN Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code IP;140
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21695-065-06 6 in 1 BOTTLE
    2 NDC:21695-065-14 14 in 1 BOTTLE
    3 NDC:21695-065-28 28 in 1 BOTTLE
    4 NDC:21695-065-30 30 in 1 BOTTLE
    5 NDC:21695-065-50 50 in 1 BOTTLE
    6 NDC:21695-065-60 60 in 1 BOTTLE
    7 NDC:21695-065-90 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA071333 12/16/2009
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distributors Corp 118802834 RELABEL, REPACK