NDC Code(s) : 41520-384-21
Packager : American Sales Company

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CareOne Cough DMdextromethorphan polistirex SUSPENSION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-384
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)
D&C RED NO. 30(UNII: 2S42T2808B)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
GLYCERIN(UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP(UNII: XY6UN3QB6S)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POLYVINYL ACETATE(UNII: 32K497ZK2U)
POVIDONE, UNSPECIFIED(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:41520-384-211 in 1 CARTON 30/08/2012
189 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091135 08/30/2012

LABELER - American Sales Company(809183973)

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Delsym®

COUGH DM

Dextromethorphan Polistirex

Extended–Release Oral Suspension

Cough Suppressant

12hr

Cough Relief

Day or Night

Alcohol–Free

dosing cup included

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

OUR PHARMACISTS RECOMMEND

Orange–Flavored Liquid

3 FL OZ (89mL)

384OF-cough-dm