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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:  03/21/2013
 
Trade Name:  Phenylephrine Hydrochloride
 
Generic Name or Proper Name (*):  phenylephrine hydrochloride
 
Indications Studied:  Dilation of the pupil
 
Label Changes Summary:  *The 2.5% solution are approved for use in pediatric patients of all ages*The 10% solution is approved for patients 1 year and older and contraindicated in pediatric patients < 1 year of age due to the increased risk of systemic toxicity*New Drug
 
Product Labeling:    Opens a new window
 
PREA(P):  P
 
Sponsor:  Paragon BioTech, Inc.
 
NNPS:  TRUE
 
Therapeutic Category:  Ophthalmologic
 
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