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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:  04/15/2008
 
Trade Name:  Patanase Nasal Spray
 
Generic Name or Proper Name (*):  olopatadine hydrochloride
 
Indications Studied:  Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older
 
Label Changes Summary:  Safety and effectiveness in children below the age of 12 years have not been established Symptoms of antihistamine overdose in children may initially include agitation and restlessness followed by drowsiness Efficacy and safety were evaluated in 3 clinical trials of 2 weeks duration in adult and adolescent patients, 12 years of age and older, with symptoms of SAR Dosage and administration information provided for children 12 years and older New indication, dosage form, dosing regimen, and route of administration
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Alcon Research, Ltd.
 
NNPS:  FALSE'
 
Therapeutic Category:  Antihistamine
 
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