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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:  10/21/2002
Trade Name:  Zyrtec
Generic Name or Proper Name (*):  cetirizine
Indications Studied:  Perennial Allergic Rhinitis & Chronic Urticaria
Label Changes Summary:  * Extended the age range from 2 years to 6 months * Information on dose, PK parameters and AE profile
Product Labeling:  Labeling  Opens a new window
Sponsor:  Pfizer
Pediatric Exclusivity Granted Date:  03/13/2002
Therapeutic Category:  Antihistamine