Label: IBUPROFEN IMMEDIATE RELEASE- ibuprofen tablet, coated

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

Drug Label Information

Updated November 18, 2014

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

  • ACTIVE INGREDIENT(S)

    (in each brown tablet)
    Ibuprofen USP 200 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever/fever reducer

  • USE(S)

    • 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 an nonsteroidal anti-inflammatory drug (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

    • 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

    • 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
  • 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 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)
    • tamper evident: do not use if imprinted safety seal under cap is broken or missing
    • see end panel for lot number and expiry date
  • INACTIVE INGREDIENT (S)

    colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, sodium starch glycolate, titanium dioxide, triacetin and talc



    QUESTIONS OR COMMENTS?
    Adverse drug event Call: (877) 586-7979

  • PRINCIPAL DISPLAY PANEL

    Package Label (Round Shaped Tablets) - Principal Display Panel - 50s - Count Carton, 200 mg Tablets

    DISCOUNT
    drug mart
    FOOD FAIR
    NDC 53943-401-09
    SEE NEW WARNINGS INFORMATION
    IBUPROFEN
    TABLETS, USP 200 mg
    Pain Reliever / Fever Reducer (NSAID)*
    IBU
    200
    50 COATED TABLETS
    *nonsteroidal anti-inflammatory drug
    Compare to the Active Ingredient of ADVIL@**
    **This product is not manufactured or distributed by Pfizer Inc. owner of the registered trade mark Advil@
    ibuprofen-round-carton

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  IMMEDIATE RELEASE
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-401
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TALC (UNII: 7SEV7J4R1U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUND (ROUND SHAPED) Size10mm
    FlavorImprint Code IBU200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-401-091 in 1 CARTON
    150 in 1 BOTTLE
    2NDC:53943-401-101 in 1 CARTON
    2100 in 1 BOTTLE
    3NDC:53943-401-15500 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07912912/22/2014
    Labeler - Discount Drug Mart (047741335)
    Registrant - Shasun Pharmaceuticals Limited (915786829)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shasun Pharmaceuticals Limited915786829MANUFACTURE(53943-401)