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Ibuprofen (Weeks & Leo Co., Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 1 BOTTLE in 1 CARTON (11383-151-50) > 50 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (11383-151-21) > 200 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (11383-151-11) > 100 TABLET, COATED in 1 BOTTLE Label Information

Complete Ibuprofen Information

  • ACTIVE INGREDIENT(S)

    Ibuprofen 200 mg (NSAID)*

    * nonstreoidal anti-inflammatory drug


  • PURPOSE

    Pain reliever / fever reducer


  • USE(S)

    • temporarily relieves minor aches and pain due to :
    • backache
    • headache
    • menstrual cramps
    • minor pain of arthritis
    • muscular aches
    • the common cold
    • toothache
    • temporarily reduces fever

  • WARNINGS

    Allergy alerts: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.

    Symptoms may include: 

    • asthma (wheezing)
    • blisters
    • facial swelling
    • hives
    • rash
    • shock
    • skin reddening

    If an allergic reaction occurs, stop use and seek medical help right away.

    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 bad stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drug containing prescription NSAID (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • the 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
    • 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 diuretics
    • reached age 60 or older

  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF

    you are

    • taking any other drugs containg an NSAID (prescription or nonprescription)
    • taking a blood thining (anticoagulant) or steriod drug
    • under a doctor’s care for any serious condition
    • taking aspirin for heart attacks or stroke, because ibuprofen may decrease this benefit of aspirin
    • taking any other drug

  • WHEN USING THIS PRODUCT

    • take with food or milk if stomach upset occurs
    • long term continuous use may increase the risk of heart attack or stroke

  • STOP USE AND ASK 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 painful area
    • any new symptoms appear

  • PREGNANCY/BREASTFEEDING

    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 a 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 years
    • ask a doctor

  • STORAGE

    • Store between 20-250C(68-77 0F).
    • Do not use if seal under bottle cap imprinted with "SEALED  for YOUR PROTECTION" is broken or missing.

  • INACTIVE INGREDIENTS

    colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, titanium dioxide.


  • PRINCIPAL DISPLAY PANEL

    Carton Label PDP

    Ibuprofen 200mg CAPLET

    PAIN RELIEVER/ FEVER REDUCER (NSAID)

    ibubr cap



    Ibu-cap-br


    Ibu-cap-br


    Ibu-cap-br


    ibu-cap-br



  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11383-151
    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
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    Product Characteristics
    Color BROWN Score no score
    Shape CAPSULE Size 15mm
    Flavor Imprint Code 117
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11383-151-50 1 in 1 CARTON
    1 50 in 1 BOTTLE
    2 NDC:11383-151-11 1 in 1 CARTON
    2 100 in 1 BOTTLE
    3 NDC:11383-151-21 1 in 1 CARTON
    3 200 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091239 05/17/2013
    Labeler - Weeks & Leo Co., Inc. (005290028)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    Name Address ID/FEI Business Operations
    Marksans Pharma Limited 925822975 MANUFACTURE(11383-151)