Active Ingrident
(in each 5 ml)
Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Taro Pharmaceuticals U.s.a., Inc. for the product Ibuprofen (NDC 51672-5321). 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 active ingrident, purpose, uses, allergy alert:, stomach bleeding warning:, heart attack and stroke warning:, sore throat warning:, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each 5 ml)
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:
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.
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.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
*or as directed by a doctor | ||
| Weight (lb) | Age (yr) | Dose (mL)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 lbs | 2-3 years | 5 mL |
| 36-47 lbs | 4-5 years | 7.5 mL |
| 48-59 lbs | 6-8 years | 10 mL |
| 60-71 lbs | 9-10 years | 12.5 mL |
| 72-95 lbs | 11 years | 15 mL |
acesulfame potassium, anhydrous citric acid, glycerin, hypromellose, mix berry flavor, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum
Call 1-877-244-9825
*All trademarks are the property of their respective owners.
Manufactured for:
Taro Pharmaceuticals U.S.A., Inc.
Hawthrone, NY 10532
TARO is a registered trademark of
Taro Pharmaceuticals U.S.A., Inc.
Made in India
Revised: 08/2024
See New Warnings
NDC 51672-5321-8
For Ages 2 to 11 Years
Children's Ibuprofen Oral Suspension, USP (NSAID)
100 mg per 5 mL
Pain Reliever / Fever Reducer
Lasts up to
8 hours
Dye-Free
Alcohol Free
Berry Flavor
4 fl oz (120 mL)
* Please review the disclaimer below.