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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:  04/29/2004
 
Trade Name:  Mucinex DM Extended-release Tablet
 
Generic Name or Proper Name (*):  guaifenesin; dextromethorphan
 
Indications Studied:  Expectorant and cough suppressant in children 12 years of age and older
 
Label Changes Summary:  * 505(b)(2) approved with no pediatric information * Age range based on monograph * Do not use in children under 12 years of age * studies waived in children < 12 years of age due to safety concerns * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Adams Respiratory Therapeutics
 
NNPS:  FALSE
 
Therapeutic Category:  Cough suppressant
 
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