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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:  07/30/2004
 
Trade Name:  Claritin-D 12 Hour Extended-Release Tablets Claritin-D 24 Hour Extended-Release Tablets
 
Generic Name or Proper Name (*):  loratadine; pseudoephedrine
 
Indications Studied:  Temporary relief of nasal congestion due to the common cold in children 12 years of age and older OTC
 
Label Changes Summary:  * Approval based on monograph and previous studies for other indication * No new studies submitted * Studies in children birth - 12 years of age waived * New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Schering-Plough
 
NNPS:  TRUE
 
Therapeutic Category:  Antihistamine
 
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