Label: DYE FREE CHILDRENS IBUPROFEN- ibuprofen suspension

  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 12, 2017

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


    Berry Flavor

    100 mg/5 mL

    For Hospital Use Only

    Drug Facts

  • Active ingredient (in each 5 mL = 1 teaspoonful)

    Ibuprofen 100 mg (NSAID)1

    nonsteroidal anti-inflammatory drug
  • Purposes

    Pain reliever/fever reducer

  • Uses


    • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
    • reduces fever
    • Important: Read all product information before using.
    • This product is intended for use in children.
  • 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

    • 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, 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

    • give 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 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

    • use as directed per healthcare professional
    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed
    • shake well before using
    • mL = milliliter; tsp = teaspoonful
    • find right dose on chart. 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) Dose (mL or tsp)*
    or as directed by a doctor
    under 24 lbs under 2 years ask a doctor
    24-35 lbs 2-3 years 5 mL (1 tsp)
    36-47 lbs 4-5 years 7.5 mL (1½ tsp)
    48-59 lbs 6-8 years 10 mL (2 tsp)
    60-71 lbs 9-10 years 12.5 mL (2½ tsp)
    72-95 lbs 11 years 15 mL (3 tsp)
  • Other information

    • each 5 mL (1 tsp) contains: sodium 2 mg
    • store at 20-25°C (68-77°F)
    • do not freeze
    • see individual label or shipper for lot number and expiration date
  • Inactive ingredients

    anhydrous citric acid, artificial mixed berry flavor, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum


    Alcohol Free, Dye Free, Gluten Free

  • How Supplied

    NDC 68094-600-61
    5 mL per unit dose cup
    One hundred (100) cups per shipper

    NDC 68094-600-62
    5 mL per unit dose cup
    Thirty (30) cups per shipper


    Distributed By
    Perrigo Company
    Allegan, MI 49010

    Packaged By
    Precision Dose, Inc.
    South Beloit, IL 61080

    LI 979   Rev. 03/17

  • PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Cup Label

    NDC 68094-600-59

    Children's IBUPROFEN
    Oral Suspension
    100 mg/5 mL

    Pkg: Precision Dose, Inc., S. Beloit, IL 61080

    Principal Display Panel - 100 mg/5 mL Cup Label
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-600(NDC:0113-0685)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Anhydrous citric acid (UNII: XF417D3PSL)  
    Glycerin (UNII: PDC6A3C0OX)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    xanthan gum (UNII: TTV12P4NEE)  
    high fructose corn syrup (UNII: XY6UN3QB6S)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor BERRY Imprint Code
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68094-600-62 3 in 1 CASE 08/26/2015
    1 10 in 1 TRAY
    1 NDC:68094-600-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2 NDC:68094-600-61 10 in 1 CASE 08/26/2015
    2 10 in 1 TRAY
    2 NDC:68094-600-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074937 08/26/2015
    Labeler - Precision Dose Inc. (035886746)