IBUPROFEN TABLET, COATED [VELOCITY PHARMA]

IBUPROFEN TABLET, COATED [VELOCITY PHARMA]
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NDC 76168-095-20, 76168-095-24, 76168-095-30
Set ID 65512647-3b27-4fb4-861e-a05aa094abe4
Category HUMAN OTC DRUG LABEL
Packager Velocity Pharma
Generic Name
Product Class
Product Number
Application Number ANDA091239
  • 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, corn starch, Croscarmellose Sodium, hypermellose, Iron Oxide red, lactose monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, povidone, Pregelatinized Starch, stearic acid, Talc, Titanium Dioxide, triacetin

  • Questions or Comments

    Call toll free 1-855-314-1850

  • PRINCIPAL DISPLAY PANEL

    Ibu_30ct

    Ibu_200ct

    Ibu_24ct

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-095
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code Ibu200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76168-095-2424 in 1 BOTTLE03/27/2019
    11 in 1 CARTON; Type 0: Not a Combination Product
    2NDC:76168-095-3030 in 1 BOTTLE03/27/2019
    21 in 1 CARTON; Type 0: Not a Combination Product
    3NDC:76168-095-20200 in 1 BOTTLE03/27/2019
    31 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123903/27/2019
    Labeler - Velocity Pharma (962198409)

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