Acetaminophen and Codeine Phosphate (Page 6 of 6)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 300 mg/30 mg (15 Tablet Bottle)

NDC 63187-815-15
Acetaminophen and Codeine Phosphate Tablets, USP
300 mg/30 mg CIII
Rx only 15 Tablets

63187-815-15
(click image for full-size original)
ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-815(NDC:13107-059)
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE (120 .MU.M)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
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:63187-815-15 15 TABLET in 1 BOTTLE None
2 NDC:63187-815-20 20 TABLET in 1 BOTTLE None
3 NDC:63187-815-30 30 TABLET in 1 BOTTLE None
4 NDC:63187-815-60 60 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 — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (63187-815)

Revised: 04/2022 Proficient Rx LP

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.