NDC Code(s) : 63629-2959-1
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-2959(NDC:0472-1629)
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROMETHAZINE HYDROCHLORIDE(UNII: R61ZEH7I1I)
(PROMETHAZINE - UNII:FF28EJQ494) 		PROMETHAZINE HYDROCHLORIDE6.25 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE5 mg in 5 mL
CODEINE PHOSPHATE(UNII: GSL05Y1MN6)
(CODEINE ANHYDROUS - UNII:UX6OWY2V7J) 		CODEINE PHOSPHATE10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID(UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
METHYLPARABEN(UNII: A2I8C7HI9T)
TANGERINE(UNII: KH3E3096OO)
Product Characteristics
Color YELLOW (Orange) Score
Shape Size
Flavor FRUIT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-2959-1120 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088764 12/19/2011

PRINCIPAL DISPLAY PANEL

Promethazine VC w/Codeine (CV) Syrup

Label