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Ibuprofen (Velocity Pharma)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 40 CARTON in 1 BOTTLE (76168-012-08) > 1 TABLET, COATED in 1 CARTON Label Information

Complete Ibuprofen Information

  • Active Ingredient

    (in each tablet)

    Ibuprofen 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
    • minor pains of arthritis
    • muscular aches
    • the common cold
    • temporarily reduces fever

  • Warnings

    Allergy alert: This product may cause a severe allergic reaction, especially in people allergic to aspirin, symptoms may include

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

    • this product if you have ever had an allergic reaction to any pain reliever/fever reducer
    • right before or after heart surgery

    ask your doctor before use if

    • 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

    ask your 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 the benefit of aspirin
    • taking any other drug

    when using this product

    • take with food or milk
    • The risk of heart attack or stroke may increase if you are more than directed or for longer than directed

    Stop use and ask a doctor if:

    • you experience and 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 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
    • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persists.
    • 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)
    • do not use if imprinted safety seal under the cap is broken or missing

  • Inactive Ingredients

    Colloidal silicon Dioxide, Croscarmellose Sodium, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Pregelatinized Starch, Talc, Titanium Dioxide


  • Questions or Comments

    Call toll free 1-855-314-1850


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    62377580-figure-01

    62377580-figure-02

    NDC: 76168-012-08 – 40 COUNT


  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76168-012
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BROWN Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 114
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76168-012-08 40 in 1 BOTTLE
    1 1 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091239 07/01/2012
    Labeler - Velocity Pharma (962198409)