ACETAMINOPHEN AND CODEINE PHOSPHATE (Page 6 of 6)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 300 mg/30 mg Bottle

Repackaged by:

Aidarex Pharmaceuticals, LLC, Corona, CA 92880

NDC 53217-0370

Acetaminophen and Codeine Phosphate
Tablets USP

CIII

300 mg/30 mg

Each tablet contains:
Acetaminophen USP . . . . . . . . . . . . 300 mg
Codeine Phosphate USP. . . . . . . . . . 30 mg

Rx only

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Mallinckrodt

L00A34Rev 08/2017

53217-0370_APAP-COD-PHO_300MG_30MG
(click image for full-size original)

53217-0370_APAP-COD-PHO_300MG_30MG

ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-370(NDC:0406-0484)
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
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 3;M
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-370-20 20 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040419 04/03/2018
Labeler — Aidarex Pharmaceuticals LLC (801503249)
Establishment
Name Address ID/FEI Operations
Aidarex Pharmaceuticals 801503249 REPACK (53217-370)

Revised: 08/2018 Aidarex Pharmaceuticals LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.