Other
Berry Flavor
100 mg/5 mL
For Hospital Use Only
Drug Facts
Alcohol Free, Dye Free, Gluten Free
Distributed By
Perrigo Company
Allegan, MI 49010
Packaged By
Precision Dose, Inc.
South Beloit, IL 61080
LI 979 Rev. 03/17
The following Structured Product Label (SPL) was submitted to the FDA by Precision Dose Inc. for the product Dye Free Childrens Ibuprofen (NDC 68094-600). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml = 1 teaspoonful), purposes, uses, allergy alert, stomach bleeding warning, sore throat warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Berry Flavor
100 mg/5 mL
For Hospital Use Only
Drug Facts
Alcohol Free, Dye Free, Gluten Free
Distributed By
Perrigo Company
Allegan, MI 49010
Packaged By
Precision Dose, Inc.
South Beloit, IL 61080
LI 979 Rev. 03/17
Ibuprofen 100 mg (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
temporarily:
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child:
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.
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)
| 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) |
anhydrous citric acid, artificial mixed berry flavor, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum
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
* Please review the disclaimer below.