Label: IBUPROFEN- ibuprofen capsule, liquid filled

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/13

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

  • Active ingredient (in each capsule)

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

    (present as the free acid and potassium salt)
    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    • 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
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  • 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 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

    • the 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 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 attack 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
    • 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 right away.

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  • 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 does 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
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  • Other information

    • each capsule contains: potassium 20 mg
    • read all warnings and directions before use. Keep carton.
    • store at 20° to 25°C (68° to 77°F)
    • avoid excessive heat above 40°C (104°F). Protect from light.
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  • Inactive ingredients

    FD&C blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

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  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM- 5PM EST

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  • Principal Display Panel

    †COMPARE TO THE ACTIVE INGREDIENT IN ADVIL® LIQUI-GELS®

    Ibuprofen CAPSULES 200 mg

    PAIN RELIEVER/FEVER REDUCER (NSAID)

    SOFTGELS**

    (**LIQUID FILLED CAPSULES)

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Do not use if tamper-evident seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" is broken or missing.

    †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Liqui-Gels®.

    DISTRIBUTED BY:

    CHAIN DRUG CONSORTIUM, LLC.

    3301 NW BOCA RATON BLVD., SUITE 101

    BOCA RATON, FL 33431

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  • Product Label

    Ibuprofen 200 mg

    Premier Value Ibuprofen 200 mg Capsules

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  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68016-116(NDC:10888-7133)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1  
    GELATIN  
    POLYETHYLENE GLYCOLS  
    POTASSIUM HYDROXIDE  
    WATER  
    SORBITAN  
    SORBITOL  
    Product Characteristics
    Color BLUE (light blue) Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code IB200
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68016-116-02 1 in 1 BOX
    1 40 in 1 BOTTLE
    2 NDC:68016-116-01 1 in 1 BOX
    2 80 in 1 BOTTLE
    3 NDC:68016-116-00 1 in 1 BOX
    3 180 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078682 07/08/2010
    Labeler - Premier Value (Chain Drug Consortium, LLC) (101668460)
    Registrant - P and L Development of New York Corporation (800014821)
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