NDC Code(s) : 0031-8725-10, 0031-8726-10
Packager : GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex SUSPENSION, EXTENDED RELEASE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8725
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)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
SODIUM POLYSTYRENE SULFONATE(UNII: 1699G8679Z)
SUCROSE(UNII: C151H8M554)
TARTARIC ACID(UNII: W4888I119H)
TRAGACANTH(UNII: 2944357O2O)
TRIACETIN(UNII: XHX3C3X673)
WATER(UNII: 059QF0KO0R)
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:0031-8725-101 in 1 CARTON 07/05/2016
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 07/05/2016
Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex SUSPENSION, EXTENDED RELEASE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8726
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)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
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)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
SODIUM POLYSTYRENE SULFONATE(UNII: 1699G8679Z)
SUCROSE(UNII: C151H8M554)
TARTARIC ACID(UNII: W4888I119H)
TRAGACANTH(UNII: 2944357O2O)
TRIACETIN(UNII: XHX3C3X673)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color purple Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0031-8726-101 in 1 CARTON 07/05/2016
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 07/05/2016

LABELER - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC(079944263)

PRINCIPAL DISPLAY PANEL

NEW!

Children's
Robitussin ®

For adults & children
AGES 4 & OVER

EXTENDED-RELEASE

12 Hour
Cough Relief

DEXTROMETHORPHAN POLISTIREX EXTENDED-
RELEASE ORAL SUSPENSION (Cough Suppressant)

12 Hour
Cough Relief

DAY or NIGHT

Orange Flavored Liquid
Alcohol-Free

3 FL OZ (89 mL)

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

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton - Orange

PRINCIPAL DISPLAY PANEL

NEW!

Children's
Robitussin ®

For adults & children
AGES 4 & OVER

EXTENDED-RELEASE

12 Hour
Cough Relief

DEXTROMETHORPHAN POLISTIREX EXTENDED-
RELEASE ORAL SUSPENSION (Cough Suppressant)

12 Hour
Cough Relief

DAY or NIGHT

Grape Flavored Liquid
Alcohol-Free

3 FL OZ (89 mL)

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

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton - Grape