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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:  12/17/2004
Trade Name:  Augmentin ES-600 Powder for Oral Suspension
Generic Name or Proper Name (*):  amoxicillin; clavulanate
Indications Studied:  Treatment of acute bacterial sinusitis (ABS) (sinus infection) in children 3 months of age and older
Label Changes Summary:  * No new pediatric studies * Effectiveness extrapolated from adult studies for Augmentin XR for ABS and from studies in pediatric patients with otitis media and by similar pharmacokinetics in pediatric patients * New indication
Product Labeling:  Labeling  Opens a new window
Sponsor:  GlaxoSmithKline
Therapeutic Category:  Antibiotic