Label: IBUPROFEN tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 19, 2010

If you are a consumer or patient please visit this version.

  • 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
    • muscular aches
    • minor pain or 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.

    Alcohol Warning: If you consume 3 or more alcohol drinks per day, ask your Doctor whether you should take Ibuprofen or other pain relievers/fever reducers.

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 NSAID (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 DOCTOR

    Ask a doctor before use if you have

    • problems or serious side effects from taking pain relievers or fever reducers
    • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
    • ulcers
    • bleeding problems
    • high blood pressure
    • heart or kidney disease
    • taken a diuretic
    • reached age 60 or older

    Ask a doctor before use if you are

    • taking aspirin for heart attack or stroke because ibuprofen may decrease this benefit of aspirin
    • taking any other drug containing an NSAID (prescription or nonprescription)
    • taking a blood thinning (anticoagulant) or steroid drug
    • under a doctor's care for any serious condition
    • taking any other drug
    • consuming 3 or more alcohol drinks per day
  • WHEN USING THIS PRODUCT

    • take with food or milk if stomach upset occurs
    • long term continuous use ay increase the risk of heart attack or stroke
  • STOP USE AND ASK A DOCTOR IF

    • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • stomach pain or upset gets worse or lasts
    • 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 1-800-362-0101 (Arizona only) immediately.
  • DIRECTIONS

    • do not take longer than 10 days, unless directed by a doctor (see Warnings)


    Adults and children 12 years and older
    • take 1 caplet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 caplet, 2 caplets may be used
    • do not exceed 6 caplets in a 24-hour period, unless directed by a physician
    • take with food or milk, if occasional and mild heartburn, upset stomach, or stomach pain occurs with use
    • consult a physician if these symptoms are more thsn mild or if they persist
    Children under 12 years
    • not for use
  • OTHER INFORMATION

    Other information
    • store at 15 – 30°C (59-86°F).
    Inactive ingredients

    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, Titanium Dioxide.


  • QUESTIONS OR COMMENTS

    Call 1-800-262-5244

    Monday though Friday 9AM – 2PM MST

    Distributed by:

    RejuviLife, Phoenix, AZ

    RejuviLife is a trademark of Apotheca Inc.

  • PACKAGE LABEL,PRINCIPAL DISPLAY PANEL,ADDITIONAL LABELS UPON REQUEST

    NDC 12634-860-01

    IBUPROFEN

    MAXIMUM STRENGTH
    WITHOUT A PRESCRIPTION

    Pain Reliever
    Fever Reducer

    RejuviLife®

    100 CAPLETS

    200 MG

    image of label

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12634-860(NDC:53746-142)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorbrown (BROWN) Scoreno score
    ShapeOVAL (CAPSULE-SHAPE) Size13mm
    FlavorImprint Code IP;142
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12634-860-2424 in 1 BOTTLE, PLASTIC
    2NDC:12634-860-01100 in 1 BOTTLE, PLASTIC
    3NDC:12634-860-101000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07133309/16/2009
    Labeler - Apotheca Inc. (051457844)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Inc.051457844relabel, repack