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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:  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 years* New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bayer HealthCare, LLC – Consumer Care
 
NNPS:  FALSE
 
Therapeutic Category:  anti-inflammatory+sleep aid
 
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