Label: IBUPROFEN- ibuprofen tablet, chewable

  • 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 06/09

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

  • Active ingredient (in each tablet)

    Ibuprofen 100 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    temporarily:

    • reduces fever
    • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
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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 your child:

    • has had stomach ulcers or bleeding problems
    • takes a blood thinning (anticoagulant) or steroid drug
    • takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • takes more or for a longer time than directed

    Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

    Do not use

    • if the child has ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or after heart surgery

    Ask a doctor before use if

    • child has problems or serious side effects from taking pain relievers or fever reducers
    • stomach bleeding warning applies to your child
    • child has a history of stomach problems, such as heartburn
    • child has not been drinking fluids
    • child has lost a lot of fluid due to vomiting or diarrhea
    • child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • child has asthma
    • child is taking a diuretic

    Ask a doctor or pharmacist before use if the child is

    • under a doctor’s care for any serious condition
    • taking any other drug

    When using this product

    • mouth or throat burning may occur; give with food or water
    • 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

    • child experiences any of the following signs of stomach bleeding:
    • feels faint
    • vomits blood
    • has bloody or black stools
    • has stomach pain that does not get better
    • the child does not get any relief within the first day (24 hours) of treatment
    • fever or pain gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear

    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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  • Directions

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed
    • find the right dose on chart below. If possible, use weight to dose; otherwise use age.
    • if needed, repeat dose every 6-8 hours
    • do not use more than 4 times a day
    Dosing Chart
    Weight (lb) Age (yr) Tablets
    under 24 under 2 ask a doctor
    24-35 2-3 1
    36-47 4-5 1 ½
    48-59 6-8 2
    60-71 9-10 2 ½
    72-95 11 3
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  • Other information

    • phenylketonurics: contains phenylalanine 6 mg per tablet 
    • do not use if printed seal under cap is broken or missing
    • store at 20-25°C (68-77°F)
    • see end panel for lot number and expiration date
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  • Inactive Ingredients

    acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, prosweet, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to active ingredient in Motrin® Junior Strength

    See new warnings information

    FOR AGES 2-11

    JUNIOR STRENGTH IBUPROFEN TABLETS

    IBUPROFEN TABLETS, 100mg

    Pain reliever/Fever reducer (NSAID)

    Lasts up to 8 HOURS

    Ibuprofen Carton Image 1

    Ibuprofen Carton Image 1

    Ibuprofen Carton Image 2

    Ibuprofen Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-521
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM  
    ASPARTAME  
    CROSCARMELLOSE SODIUM  
    MAGNESIUM STEARATE  
    MANNITOL  
    SILICON DIOXIDE  
    SODIUM LAURYL SULFATE  
    SOYBEAN OIL  
    SUCCINIC ACID  
    CARNAUBA WAX  
    HYPROMELLOSES  
    Product Characteristics
    Color PURPLE (Lavender) Score 2 pieces
    Shape ROUND Size 12mm
    Flavor GRAPE Imprint Code L521
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-521-62 1 in 1 CARTON
    1 24 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076359 11/05/1991
    Labeler - CVS Pharmacy (062312574)
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