Acetaminophen and Codeine Phosphate (Page 11 of 11)

Acetaminophen 120mg & Codeine 12mg Solution C-V

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ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen and codeine phosphate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-3410(NDC:0121-0504)
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 120 mg in 5 mL
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 12 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
FD&C RED NO. 40
FD&C YELLOW NO. 6
GLYCERIN
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SUCROSE
Product Characteristics
Color orange Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53002-3410-1 118 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087508 08/21/1981
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-3410)

Revised: 12/2020 RPK Pharmaceuticals, Inc.

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