Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
PREA(P):
P
Sponsor:
Adams Respiratory Therapeutics
NNPS:
FALSE'
Therapeutic Category:
Cough suppressant
-
-