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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:
01/17/2014
Trade Name:
Aleve PM
Generic Name or Proper Name (*):
naproxen sodium 220 mg and diphenhydramine hydrochloride 25 mg
Indications Studied:
Relief of occasional sleeplessness when associated with minor aches and pains and helps fall asleep and stay asleep
Label Changes Summary:
Approved for use in adults and children 12 years and older Not approved for use in children less than 12 yearsNew drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Bayer HealthCare, LLC – Consumer Care
NNPS:
FALSE'
Therapeutic Category:
anti-inflammatory+sleep aid
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