DYE FREE CHILDRENS IBUPROFEN- ibuprofen suspension 
Precision Dose Inc.



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


Pain reliever/fever reducer




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)


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

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


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)

Revised: 7/2017
Document Id: d1d0316f-a312-42eb-bf74-d9c1e1163918
Set id: eccee4c6-aa94-468a-aebd-265d7a9efb6d
Version: 2
Effective Time: 20170712
Precision Dose Inc.