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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
01/12/2000
Trade Name:
Advil
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 (14,291 patients)
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Whitehall
Pediatric Exclusivity Granted Date:
07/01/1998
NNPS:
FALSE'
Therapeutic Category:
Analgesic; Antipyretic
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