NDC Code(s) : 21130-385-04, 21130-385-08
Packager : Safeway, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Adult Cough and Chest Congestion Relief DM Dextromethorphan HBr, Guaifenesin LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-385
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE(UNII: 9D2RTI9KYH)
(DEXTROMETHORPHAN - UNII:7355X3ROTS) 		DEXTROMETHORPHAN HYDROBROMIDE20 mg in 10 mL
GUAIFENESIN(UNII: 495W7451VQ)
(GUAIFENESIN - UNII:495W7451VQ) 		GUAIFENESIN200 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
SODIUM BENZOATE(UNII: OJ245FE5EU)
FD&C RED NO. 40(UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP(UNII: XY6UN3QB6S)
MENTHOL(UNII: L7T10EIP3A)
GLUCOSE OXIDASE(UNII: 0T8392U5N1)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:21130-385-041 in 1 BOX 30/06/2014
1118 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:21130-385-081 in 1 BOX 30/06/2014
2237 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 06/30/2014

LABELER - Safeway, Inc.(009137209)

PRINCIPAL DISPLAY PANEL

COMPARE TO Robitussin® Cough + Chest Congestion DM active ingredients**

TUSSIN

COUGH & CHEST CONGESTION DM

FOR AGES 12 AND OVER

DEXTROMETHORPHAN HBr, 20 mg

Cough Suppressant

GUAIFENESIN 200 mg

Expectorant

Alcohol-Free

Relieves

  • Cough
  • Mucus

**This product is not manufactured or distributed by Haleon group of companies distributors of Robitussin® Cough + Chest Congestion DM.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY:

BETTER LIVING BRANDS LLC

P.O BOX 99,

PLEASANTON, CA 94566-0009

PRINCIPAL DISPLAY PANEL

Dextromethorphan HBr 20 mg, Guaifenesin 200 mg Signature Care ADULT COUGH AND CHEST CONGESTION RELIEF DM