NDC Code(s) : 37205-697-21
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

leader cough dmdextromethorphan polistirex SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37205-697
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE(UNII: 9D2RTI9KYH)
(DEXTROMETHORPHAN - UNII:7355X3ROTS) 		DEXTROMETHORPHAN HYDROBROMIDE30 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
POLISTIREX(UNII: 5H9W9GTW27)
HIGH FRUCTOSE CORN SYRUP(UNII: XY6UN3QB6S)
GLYCERIN(UNII: PDC6A3C0OX)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONES(UNII: FZ989GH94E)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
SODIUM POLYSTYRENE SULFONATE(UNII: 1699G8679Z)
SUCROSE(UNII: C151H8M554)
TARTARIC ACID(UNII: W4888I119H)
TRAGACANTH(UNII: 2944357O2O)
TRIACETIN(UNII: XHX3C3X673)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color ORANGE Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37205-697-211 in 1 CARTON
189 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091135 09/13/2012

PRINCIPAL DISPLAY PANEL

Compare to Delsym® active ingredient

Cough DM

Dextromethorphan Polistirex Extended-Release Oral Suspension

Cough Suppressant

12 Hour Cough Relief

Dosing Cup Included

Orange-Flavored Liquid

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions

Alcohol-Free

Cough DM Carton Image 1Cough DM Carton Image 1