Active Ingredient (In Each 1.25 Ml)
Ibuprofen 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Hyvee Inc for the product Ibuprofen (NDC 42507-057). 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 ingredient (in each 1.25 ml), purposes, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if the child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
temporarily:
Allergy alert: 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.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the child:
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.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Dosing Chart | ||
Weight (lb) | Age (mos) | Dose (mL) |
under 6 mos | ask a doctor | |
12-17 lbs | 6-11 mos | 1.25 mL |
18-23 lbs | 12-23 mos | 1.875 mL |
anhydrous citric acid, FD&C red #40, glycerin, hypromellose, natural and artificial berry flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
1-800-719-9260
COMPARE TO the Active Ingredient of Motrin® Infants’ Drops
For Ages 6 Mos. to 23 Mos.
Infants’
Ibuprofen Oral Suspension
50 mg per 1.25 mL
Pain Reliever / Fever Reducer (NSAID)
Concentrated Drops
Original Berry Flavor
Lasts Up to 8 Hours
No High Fructose Corn Syrup
Use Only with Enclosed Syringe
0.5 FL OZ (15 mL)
* Please review the disclaimer below.