IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]

IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]
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NDC 67046-303-30
Set ID beec2bfd-1ba9-46b2-84f0-6a47766048e4
Category HUMAN OTC DRUG LABEL
Packager Contract Pharmacy Services-PA
Generic Name
Product Class
Product Number
Application Number ANDA072096
  • DRUG FACTS

  • 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:
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
    • temporarily reduces fever

  • WARNINGS

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer

    • right before or after heart surgery

    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 an 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

    Ask a doctor before use if you are

    • taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • under a doctor’s care for any serious condition
    • taking any other drugs

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

  • DIRECTIONS

    • do not take 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 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 yearsask a doctor
  • OTHER INFORMATION

    • read all warnings and directions before use
    • store at 20-25°C (68-77°F)
    • avoid high humidity and excessive heat above 40°C (104°F)
  • INACTIVE INGREDIENTS

    colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxides, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide

  • QUESTIONS OR COMMENTS?

    Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.

    call toll free 734-743-6000

    Repackaged by:

    Contract Pharmacy Services-PA
    125 Titus Ave Suite 200
    Warrington, PA 18976 USA

    Original--08/2010--NJW

  • Package Label

    Blister of 30 Tablets

    Blister of 30 Tablets

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-303(NDC:0904-7915)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code I2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67046-303-3030 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07209608/02/2010
    Labeler - Contract Pharmacy Services-PA (945429777)

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