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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
 
BPCA(B):  B
 
Sponsor:  McNeil
 
Pediatric Exclusivity Granted Date:  07/01/1998
 
NNPS:  FALSE'
 
Therapeutic Category:  Analgesic; Antipyretic
 
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