NDC Code(s) : 65162-694-86, 65162-694-90
Packager : Amneal Pharmaceuticals LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Promethazine HCl, Phenylephrine HCl, Codeine PhosphatePromethazine, Phenylephrine, Codeine SYRUP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-694
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
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
METHYLPARABEN(UNII: A2I8C7HI9T)
WATER(UNII: 059QF0KO0R)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
Product Characteristics
Color yellow (clear colorless to pale yellow) Score
Shape Size
Flavor CITRUS Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65162-694-86118 mL in 1 BOTTLE Type 0: Not a Combination Product11/01/2013
2NDC:65162-694-90473 mL in 1 BOTTLE Type 0: Not a Combination Product11/01/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200963 11/01/2013

LABELER - Amneal Pharmaceuticals LLC(123797875)

Establishment
Name Address ID/FEI Business Operations
Amneal Pharmaceuticals, LLC 963900878 analysis(65162-694), label(65162-694), manufacture(65162-694), pack(65162-694)

PRINCIPAL DISPLAY PANEL

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