Label: IBUPROFEN- ibuprofen tablet

  • NDC Code(s): 50332-0118-4, 50332-0118-7, 50332-0118-8
  • Packager: HART Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 11/12

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

  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet): Ibuprofen (NSAID)* 200mg (*nonsteroidal anti-inflammatory drug)

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  • PURPOSE

    Purpose: Pain Reliever / Fever Reducer

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  • INDICATIONS & USAGE

    Uses: Temporarily relieves minor aches and pains due to

    • headache
    • muscular aches
    • backache
    • minor arthritis pain
    • the common pain
    • toothache
    • menstrual cramps

    Temporarily reduces fever

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  • WARNINGS

    Warnings:

    Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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

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

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take more or for a longer time than directed
    • take a blood thinning (anticoagulant) or steroid drug
    • have 3 or more alcoholic drinks every day while using this product
    • take other drugs containing prescription or non-prescriptin NSAIDs (aspirin, ibuprofen, naproxen, or others)

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  • DO NOT USE

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or afte rheart surgery

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  • ASK DOCTOR

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history orstomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking any other drug containing an NSAID
    • taking a blood thinning (anticoagulant) or steroid drug
    • taking aspirin for heart attach or stroke (ibuprofen may decrease the benefit if aspirin)
    • under a doctor's care for any serious condition

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  • WHEN USING

    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
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  • STOP USE

    Stop use and ask a doctor if

    • an allergic reaction occurs, seek medical help right away
    • fever gets worse or lasts more than 3 days
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present in the painful area
    • new symptoms occur
    • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better
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  • PREGNANCY OR BREAST FEEDING

    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

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  • KEEP OUT OF REACH OF CHILDREN

    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

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  • DOSAGE & ADMINISTRATION

    Directions: Do not take more than directed; the smallest effective dose should be used.

    Adults and children 12 years of age and over:

    • take 1 tablet every 4 hours while symptoms persist
    • if pain or fever does not respond to 1 tabet, 2 tablets may be used
    • do not take more than 6 tablets in 24 hours unless directed by a doctor

    Children under 12 years of age: ask a doctor

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Carnauba Wax, Croscarmellose Sodium, FD&C Blue #2 Lake, FD&C Red #40 Lake, FD&C Yellow #6 Lake, D&C Yellow #10 Lake, Hydroxypropyl Methylcellulose, Magnesiuum Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Red Iron Oxide, Silicon Dioxide, Titanium Dioxide

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  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50332-0118
    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
    CARNAUBA WAX  
    CROSCARMELLOSE SODIUM  
    FD&C BLUE NO. 2  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    POLYSORBATE 80  
    SILICON DIOXIDE  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color brown Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code IBU200
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50332-0118-4 50 in 1 BOX, UNIT-DOSE
    1 2 in 1 PACKET
    2 NDC:50332-0118-7 125 in 1 BOX, UNIT-DOSE
    2 2 in 1 PACKET
    3 NDC:50332-0118-8 250 in 1 BOX, UNIT-DOSE
    3 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 06/03/1987
    Labeler - HART Health (069560969)
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