NDC Code(s) : 0472-1629-04, 0472-1629-08, 0472-1629-16
Packager : Actavis Mid Atlantic LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PROMETHAZINE VC WITH CODEINE PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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)
ALCOHOL(UNII: 3K9958V90M)
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:0472-1629-04118 mL in 1 BOTTLE
2NDC:0472-1629-08237 mL in 1 BOTTLE
3NDC:0472-1629-16473 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

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