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Infants Ibuprofen (Actavis Inc.)

Available Formats

Dosage Form Package Information Links
SUSPENSION 1 BOTTLE in 1 CARTON (45963-125-23) > 15 mL in 1 BOTTLE Label Information
SUSPENSION 1 BOTTLE in 1 CARTON (45963-125-24) > 30 mL in 1 BOTTLE Label Information

Complete Infants Ibuprofen Information

  • Drug Facts

  • Active ingredient (in each 1.25 mL)

    Ibuprofen 50 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/Fever reducer

  • Uses


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

  • 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

    Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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
    • stomach bleeding warning applies to your child
    • child has a history of stomach problems, such as heartburn
    • child has problems or serious side effects from taking pain relievers or fever reducers
    • 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, kidney disease, or had a stroke
    • 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
    • take with food or milk if stomach upset occurs

    Stop use and ask a doctor if
    • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
    • 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
    • child has symptoms of heart problems or stroke:
      • chest pain
      • trouble breathing
      • weakness in one part or side of body
      • slurred speech
      • leg swelling    
    • the child does not get any relief within 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).

  • Directions

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed
    • shake well before using
    • find right dose on chart below. If possible, use weight to dose; otherwise use age.
    • mL = milliliter
    • measure with the dosing device provided. Do not use with any other device.
    • dispense liquid slowly into the child's mouth, toward the inner cheek
    • if needed, repeat dose every 6 to 8 hours
    • do not use more than 4 times a day
     Dosing Chart
      Weight (lb)  Age (mos) Dose (mL)
      under 6 mos   ask a doctor
     12 to 17 lbs  6 to 11 mos 1.25 mL
     18 to 23 lbs   12 to 23 mos  1.875 mL

  • Other information

    • store between 20° to 25°C (68° to 77°F)
    • do not use if plastic bottle wrap imprinted “sealed for your protection” is broken or missing

  • Inactive ingredients

    carboxymethylcellulose sodium, citric acid anhydrous, glycerin, microcrystalline cellulose, natural and artificial berry fruit punch type flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, and xanthan gum.

  • Questions or Comments?

    1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

  • Principal Display Panel


    Compare to the active ingredient in Concentrated Motrin® Infants’ Drops†

    NDC 45963-125-23

    See New Warnings

    For Ages 6 Mos. to 23 Mos.

    Infants’ Ibuprofen

    Concentrated Ibuprofen Oral Suspension, USP


    50 mg per 1.25 mL

    Pain Reliever

    Fever Reducer

    Lasts up to 8 hours


    Use only with enclosed syringe

    Dye-Free Berry Flavor

    Alcohol Free

    ½ FL OZ (15 mL)

    1/2 oz carton

    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:45963-125
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    Does not contain ALCOHOL (UNII: 3K9958V90M) 0   in 1.25 mL
    Product Characteristics
    Color WHITE (white to off-white) Score     
    Shape Size
    Flavor BERRY Imprint Code
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45963-125-23 1 in 1 CARTON 05/11/2010
    1 15 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2 NDC:45963-125-24 1 in 1 CARTON 05/11/2010
    2 30 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079058 05/11/2010
    Labeler - Actavis Pharma, Inc. (119723554)
    Registrant - Tris Pharma Inc (947472119)