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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  04/15/1999
Trade Name:  Motrin
Generic Name or Proper Name (*):  ibuprofen
Indications Studied:  Fever, minor aches & pain, cold symptoms
Label Changes Summary:  * Extended age range from 2 years to 6 months for the over-the-counter use based on a large safety database (27,000 patients)
Product Labeling:  Labeling  Opens a new window
Sponsor:  McNeil
Pediatric Exclusivity Granted Date:  07/01/1998
Therapeutic Category:  Analgesic; Antipyretic