Acetaminophen and Codeine (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL
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ACETAMINOPHEN AND CODEINE
acetaminophen and codeine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-1772(NDC:65162-033)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 mg
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 30 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white Score no score
Shape ROUND Size 11mm
Flavor Imprint Code IP33;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-1772-6 6 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040779 01/01/2020
Labeler — RedPharm Drug, Inc. (828374897)
Establishment
Name Address ID/FEI Operations
RedPharm Drug, Inc. 828374897 repack (67296-1772), label (67296-1772)

Revised: 01/2020 RedPharm Drug, Inc.

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