NDC Code(s) : 0472-1627-04, 0472-1627-08, 0472-1627-16
Packager : Actavis Mid Atlantic LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Prometh with Codeine promethazine hydrochloride and codeine phosphate SYRUP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0472-1627
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
CODEINE PHOSPHATE(UNII: GSL05Y1MN6)
(CODEINE ANHYDROUS - UNII:UX6OWY2V7J) 		CODEINE PHOSPHATE10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
CORN SYRUP(UNII: 9G5L16BK6N)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SACCHARIN SODIUM DIHYDRATE(UNII: SB8ZUX40TY)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0472-1627-04118 mL in 1 BOTTLE
2NDC:0472-1627-08237 mL in 1 BOTTLE
3NDC:0472-1627-16473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088763 01/03/2003

PRINCIPAL DISPLAY PANEL

9943840e-figure-01