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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:  12/04/2000
Trade Name:  Claritin
Generic Name or Proper Name (*):  loratadine
Indications Studied:  Allergic rhinitis/Urticaria
Label Changes Summary:  * Labeling for 2 - 5 year olds including information on dose, PK parameters and AE profile * PK parameter in 2-5 year olds given a 5mg dose was comparable to the 10mg dose in children 6 years to adolescence
Product Labeling:  Labeling  Opens a new window
Sponsor:  Schering
Pediatric Exclusivity Granted Date:  08/14/2000
Therapeutic Category:  Antihistamine