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New Pediatric Labeling Information Database - Detail
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Pediatrics
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 agesThe 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 toxicityNew Drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Paragon BioTech, Inc.
NNPS:
TRUE'
Therapeutic Category:
Ophthalmologic
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