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IBUPROFEN (Walgreen Company)

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 1 BOTTLE in 1 CARTON (0363-0003-16) > 160 CAPSULE, LIQUID FILLED in 1 BOTTLE Label Information
CAPSULE, LIQUID FILLED 1 BOTTLE in 1 CARTON (0363-0003-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE Label Information
CAPSULE, LIQUID FILLED 1 BOTTLE in 1 CARTON (0363-0003-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE Label Information
CAPSULE, LIQUID FILLED 1 BOTTLE in 1 CARTON (0363-0003-80) > 80 CAPSULE, LIQUID FILLED in 1 BOTTLE Label Information

Complete IBUPROFEN Information

  • Active ingredient(s)


    (in each capsule)

    Solubilized Ibuprofen equal to

    200 mg ibuprofen (NSAID)*

    (present as the free acid and potassium salt)

    * nonsteroidal anti-inflammatory drug


  • Purpose


    Pain reliever/Fever reducer


  • Use(s)

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

  • Warnings

      Allergy alerts: 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 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

    • 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
    • you are taking a diuretic

  • Ask a doctor or pharmacist before use if

    • under a doctor’s care for any serious condition
    • taking aspirin for heart attack 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
    • 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 following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that dose 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 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 ControlCenter right away.(1-800-222-1222)


  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
    • if pain or fever dose not respond to 1 capsule, 2 capsules may be used
    • do not exceed 6 capsules in 24 hours, unless directed by a doctor
    • children under 12 years: ask a doctor

  • Other information

    • each capsule contains: potassium 20 mg
    • read all warnings and directions before use.
    • store at 20-25 oC (68-77 oF)
    • avoid excessive heat above 40 oC (104 oF)

  • Inactive ingredients


     Ammonium hydroxide, FD&C green no.3, Gelatin, Iron oxide black, Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitol, Sorbitan monooleate


  • Principal Display Panel

    20ct_Carton

    20ct_Carton
    20ct_Label

    20ct_Label



     
  • QUESTIONS

    Questions or Comments? 1-877-586-7979


  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  
    ibuprofen capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0003
    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
    AMMONIA (UNII: 5138Q19F1X)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Product Characteristics
    Color GREEN Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code 133
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0003-20 1 in 1 CARTON
    1 20 in 1 BOTTLE
    2 NDC:0363-0003-40 1 in 1 CARTON
    2 40 in 1 BOTTLE
    3 NDC:0363-0003-80 1 in 1 CARTON
    3 80 in 1 BOTTLE
    4 NDC:0363-0003-16 1 in 1 CARTON
    4 160 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079205 05/09/2011
    Labeler - Walgreen Company (008965063)
    Establishment
    Name Address ID/FEI Business Operations
    Aphena Pharma Solutions - Kentucky, LLC. 965013498 repack
    Establishment
    Name Address ID/FEI Business Operations
    Marksans Pharma Limited 925822975 manufacture