Acetaminophen and Codeine Phosphate (Page 6 of 6)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 300 MG/30 MG

apap/cod #6
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APAP/CODEINE 30/300MG TABS
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PACKAGE LABEL

CODEINE/ACETAMINOPHEN
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ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-1516(NDC:13107-059)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 30 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CROSPOVIDONE (15 MPA.S AT 5%)
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
SODIUM LAURYL SULFATE
STEARIC ACID
Product Characteristics
Color white (white to off white) Score no score
Shape ROUND (flat faced, beveled edge) Size 11mm
Flavor Imprint Code U36
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-1516-1 10 TABLET in 1 BOTTLE None
2 NDC:67296-1516-5 15 TABLET in 1 BOTTLE None
3 NDC:67296-1516-6 6 TABLET in 1 BOTTLE None
4 NDC:67296-1516-2 20 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202800 01/05/2017
Labeler — RedPharm Drug, Inc. (828374897)
Establishment
Name Address ID/FEI Operations
RedPharm Drug, Inc. 828374897 repack (67296-1516)

Revised: 01/2022 RedPharm Drug, Inc.

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