Acetaminophen And Codeine (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 30/300mg

NDC 67544-882 — Codeine Phosphate/APAP 30/300mg — Rx Only

Bottle Label 30/300mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60/300mg

NDC 67544-474 — Codeine Phosphate/APAP 60/300mg — Rx Only

Bottle Label 60/300mg
(click image for full-size original)

ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67544-882(NDC:0603-2338)
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
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
STARCH, CORN
SODIUM METABISULFITE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code 2064;V;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67544-882-15 15 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:67544-882-20 20 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:67544-882-30 30 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:67544-882-40 40 TABLET in 1 BOTTLE, PLASTIC None
5 NDC:67544-882-45 45 TABLET in 1 BOTTLE, PLASTIC None
6 NDC:67544-882-50 50 TABLET in 1 BOTTLE, PLASTIC None
7 NDC:67544-882-53 60 TABLET in 1 BOTTLE, PLASTIC None
8 NDC:67544-882-55 75 TABLET in 1 BOTTLE, PLASTIC None
9 NDC:67544-882-60 90 TABLET in 1 BOTTLE, PLASTIC None
10 NDC:67544-882-70 120 TABLET in 1 BOTTLE, PLASTIC None
11 NDC:67544-882-75 150 TABLET in 1 BOTTLE, PLASTIC None
12 NDC:67544-882-80 180 TABLET in 1 BOTTLE, PLASTIC None
13 NDC:67544-882-90 240 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089805 09/30/1988
ACETAMINOPHEN AND CODEINE
acetaminophen and codeine phosphate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67544-474(NDC:0603-2339)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 60 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
STARCH, CORN
SODIUM METABISULFITE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 12mm
Flavor Imprint Code 2065;V;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67544-474-30 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:67544-474-53 60 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:67544-474-60 90 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:67544-474-70 120 TABLET in 1 BOTTLE, PLASTIC None
5 NDC:67544-474-80 180 TABLET in 1 BOTTLE, PLASTIC None
6 NDC:67544-474-90 240 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089828 09/30/1988
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 Repack (67544-882), Repack (67544-474)

Revised: 12/2019 Aphena Pharma Solutions — Tennessee, LLC

Page 4 of 4 1 2 3 4

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 © 2024. All Rights Reserved.