Promethazine with Codeine (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Promethazine with Codeine Label
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Promethazine with Codeine Label

PROMETHAZINE WITH CODEINE
promethazine hydrochloride and codeine phosphate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-606
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
WATER
TRISODIUM CITRATE DIHYDRATE
EDETATE DISODIUM
SODIUM BENZOATE
SACCHARIN SODIUM
SODIUM PROPIONATE ANHYDROUS
ASCORBIC ACID
ANHYDROUS CITRIC ACID
GLYCERIN
ALCOHOL
METHYLPARABEN
FD&C BLUE NO. 1
D&C RED NO. 33
SUCROSE
Product Characteristics
Color PURPLE Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60432-606-16 473 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088875 12/17/1984
Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)
Registrant — Morton Grove Pharmaceuticals, Inc. (801897505)
Establishment
Name Address ID/FEI Operations
Morton Grove Pharmaceuticals, Inc. 801897505 ANALYSIS (60432-606), LABEL (60432-606), MANUFACTURE (60432-606), PACK (60432-606)

Revised: 05/2020 Morton Grove Pharmaceuticals, Inc.

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