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IBUPROFEN (SPIRIT PHARMACEUTICALS,LLC)

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 10 CAPSULE, LIQUID FILLED in 1 BOTTLE (68210-0009-0) Label Information

Complete IBUPROFEN Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredients (in each Capsule)

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*


  • Purpose

    Pain reliever /fever reducer


  • Uses

    • Temporarily relieves minor aches and pains due to :
      • headache
      • toothache
      • backache
      • menstrual cramps
      • the common cold
      • muscular aches
      • minor pain of arthritis
    • 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 a 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

    Heart attack and stroke warning

    NSAID's except aspirin increases the risk of heart attack, heart failure and stroke. These can be fatal. The risk is higher if you use more than directed or longer 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
    • the stomach bleeding warning applies to you
    • you have problems or serious side effects from taking pain relievers or fever reducers
    • you have 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 you are
    • 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 attach 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
    • stomach pain or upset gets worse or lasts
    • redness or swelling is present in the painful are
    • 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 ad children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
      • if pain or fever does not respond to 1 capsule, 2 capsules my 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. Keep carton.
    • store between 20° - 25°C (68° - 77°F)
    • avoid excessive heat above 40°C (104°F)

  • 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, Sorbitan monooleate, Sorbitol sorbitan


  • SPL UNCLASSIFIED SECTION

    Distributed By: Greenbrier International, Inc. Chesapeake, VA 23320


  • PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Carton

    SEE NEW WARNINGS INFORMATION

    ASSUREDâ„¢

    Compare to the active ingredient
    in Advil ® Liqui-Gels ®*

    IBUPROFENsoftgels

    LIQUID FILLED IBUPROFEN CAPSULES, 200 mg

    PAIN RELIEVER/FEVER REDUCER (NSAID)

    10 SOFTGELS

    Principal Display Panel - 200 mg Capsule Bottle Carton

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0009
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 220 mg
    Inactive Ingredients
    Ingredient Name Strength
    AMMONIA (UNII: 5138Q19F1X)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    Product Characteristics
    Color green Score no score
    Shape OVAL Size 18mm
    Flavor Imprint Code 133
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68210-0009-0 1 in 1 CARTON 11/22/2017
    1 10 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:68210-0009-1 1 in 1 CARTON 11/22/2017
    2 40 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079205 11/22/2017
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
    Registrant - SPIRIT PHARMACEUTICALS,LLC (179621011)
    Establishment
    Name Address ID/FEI Business Operations
    Marksans Pharma Ltd 925822975 manufacture(68210-0009)