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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:
02/24/2004
Trade Name:
Children's Advil Allergy Sinus Suspension
Generic Name or Proper Name (*):
chlorpheniramine; ibuprofen; pseudoephedrine
Indications Studied:
Symptoms of allergic rhinitis (runny nose) and the common cold in children 6 years of age and older
Label Changes Summary:
Effectiveness extrapolated from adult studies Bioequivalence studies in healthy adults PK and safety studies in children 6 to 12 years of age New dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Wyeth Consumer Healthcare
NNPS:
FALSE'
Therapeutic Category:
Antihistamine
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