ACETAMINOPHEN AND CODEINE PHOSPHATE (Page 11 of 11)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL

pdp
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ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2800(NDC:0406-0485)
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 60 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white (to off-white) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 4;M
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-2800-6 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040419 05/31/2001
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-2800)

Revised: 07/2022 NuCare Pharmaceuticals,Inc.

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