Children's ibuprofen goes OTC.
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.
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|Title Annotation:||from FDA Consumer, September 1995; over the counter|
|Publication:||Pediatrics for Parents|
|Date:||Apr 1, 1995|
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