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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:  08/04/2005
Trade Name:  Loperamide Hydrochloride Soft Gelatin Capsules
Generic Name or Proper Name (*):  loperamide
Indications Studied:  Control symptoms of diarrhea in children 12 years of age and older
Label Changes Summary:  * New dosage form; new dosing regimen * No new clinical studies * Bioequivalence study in adults compared the current OTC drug (Imodium caplet) and this drug * Studies waived in children 0-2 years of age
Product Labeling:  Labeling  Opens a new window
Sponsor:  Banner Pharmacaps
Therapeutic Category:  Antidiarrheal