Label: IBUPROFEN- ibuprofen tablet 

  • 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 09/12

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

  • Active Ingredient (in each caplet)

    Ibuprofen USP, 200 mg (NSAID)**

    **nonsteroidal anti-inflammatory drug

    Purpose

    Pain Releiver/ 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 an seek medical help right away.

    Stomach bleeding warning: This product contains an NSAID which may cause sever stomach bleeding. The chance is higher if you:

    • are age 60 or oder
    • have had stomach ulders or bleeding problems
    • take blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks everyday while using this prdouct
    • take more or for a longer time than directed.

    Do not use

    • if you 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 you are

    • 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 a doctor if

    • You experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stoolos
    • have stomach pain that does not bet better
    • Pain gets worse or last more than 10 days
    • Fever gets worse or last more than 3 days
    • Redness or swelling is presentin 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 druing the last 3 months of pegnancy unless defintely 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 and children 12 years and older:
    • take 1 caplet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 caplet, 2 caplets may be used.
    • do not exceed 6 caplets in 24 hours, unless directed by a doctor
    • Children under 12 years: ask a doctor
    • do not use in children under 4 years of age

    Other information

    • store between 20o- 25o C (68o- 77o F)
    • read all warnings and directions before use.
    • do not use if inner seal under bottle cap imprinted with "Sealed for your protection" is broken or missing
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  • Inactive Ingredients

    Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch (Corn), Titanium Dioxide

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  • Questions or comments?

    Call 1-800-632-6900

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  • Principal Display Panel

    Compare to the active ingredient of ADVIL® †See back panel

    SEE NEW WARNINGS INFORMATION

    Ibuprofen Tablets USP, 200 mg

    Pain Reliever/ Fever Reducer (NSAID)**

    **CAPSULE SHAPED TABLETS

    †Advil® is a registered trademark of Wyeth corporation, Madison, NJ 07940. Wyeth corporation is not affiliated with the Kroger Co. or this product

    DISTRIBUTED BY THE KROGER CO.

    CINCINNATI, OHIO 45202

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  • Product Label

    The Kroger Co. Ibuprofen Caplets

    Ibuprofen 200 mg tablets

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  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-167
    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
    ANHYDROUS LACTOSE  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    HYPROMELLOSES  
    FERRIC OXIDE RED  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    POVIDONES  
    SODIUM LAURYL SULFATE  
    SODIUM STARCH GLYCOLATE TYPE A CORN  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color BROWN Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code IP142
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-167-05 500 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA072199 02/02/2011
    Labeler - The Kroger Co. (006999528)
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