Children's ibuprofen goes OTC

Pediatrics for Parents, April, 1995

A doctor's prescription will no longer be needed for a children's form of Motrin (ibuprofen).

FDA approved Children's Motrin Oral Suspension in June. Available in pediatric strength by prescription since 1989, it is the first non-steroidal anti-inflammatory drug approved for pediatric, over-the-counter (OTC) use.

It is approved to reduce fever and relieve minor aches and pain due to colds, flu, sore throat, headaches, and toothaches in children ages 2 to 11. Doses are based on age and weight. The labeling advises parents: * Not to give the drug to a child for more than three days without a doctor's approval * To call a doctor if the child doesn't improve within 24 hours after the first dose or appears to worsen * Not to give the drug to a child allergic to aspirin or a child dehydrated due to continued vomiting, diarrhea, or lack of fluid intake.

Last March, an FDA advisory committee of outside experts recommended that the agency approve Children's Motrin as a nonprescription medication. The committee's decision came after presentations by the sponsor and FDA reviewers, including results from a safety study in more than 80,000 children.

Children's Motrin is one of the first OTC drugs to carry new, more consumer-friendly labeling.