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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Wyeth Consumer Healthcare
 
NNPS:  FALSE
 
Therapeutic Category:  Antihistamine
 
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