Children's Motrin OTC switch endorsed by advisory committees for fever reduction, analgesia.

Executive Summary

CHILDREN'S MOTRIN50184 RX-TO-OTC SWITCH FOR FEVER REDUCTION, ANALGESIA recommended for approval March 28 at a joint meeting of FDA's Nonprescription Drugs and Arthritis Advisory Committees. The advisory committees endorsed Johnson & Johnson's prescription ibuprofen product, Motrin Suspension, as an over-the-counter fever reducer and analgesic. McNeil currently markets the OTC children's analgesic Children's Tylenol with acetaminophen. FDA approved the analgesic indication for prescription Motrin Suspension tablets and caplets on March 24.