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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:
04/18/2002
Trade Name:
Advil Cold Suspension
Generic Name or Proper Name (*):
ibuprofen/ pseudoephedrine
Indications Studied:
Temporary relief of nasal and sinus congestion, headache, stuffy nose, sore throat, minor aches and pains, and fever
Label Changes Summary:
Information on the over-the-counter use in pediatric patients 2 to 11 years of age
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Whitehall
Pediatric Exclusivity Granted Date:
09/19/2001
NNPS:
FALSE'
Therapeutic Category:
Decongestant; anti-inflammatory
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