ACETAMINOPHEN AND CODEINe (Page 3 of 3)

Toxic Doses (for adults):

Acetaminophen: toxic dose 10 g
Codeine: toxic dose 240 mg

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to severity of pain and response of the patient. The usual adult dosage is:

Single Doses (range) Maximum 24 Hour Dose
Codeine Phosphate 15 mg to 60 mg 360 mg
Acetaminophen 300 mg to 1000 mg 4000 mg

The usual dose of codeine phosphate in children is 0.5 mg/kg.

Doses may be repeated up to every 4 hours.

The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.

It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.

HOW SUPPLIED

Acetaminophen and Codeine Phosphate Tablets 300 mg/30 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed “2064” and “V” on one side and debossed “3” on the reverse side. They are supplied in bottles of 30, 50, 60, 90, 100, 120, 180, 500 and 1000.

Acetaminophen and Codeine Phosphate Tablets 300 mg/60 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed “2065” and “V” on one side and debossed “4” on the reverse side. They are supplied in bottles of 100, 500 and 1000.

Dispense in a tight, light resistant container as defined in the USP/NF.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

8182436
R11/07-R2

PRINCIPAL DISPLAY PANEL

APAP-CODEINE 300-30MG LABEL IMAGE
(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:16590-023(NDC:0603-2338)
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) CODEINE PHOSPHATE 30 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
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:16590-023-12 12 TABLET (TABLET) in 1 BOTTLE None
2 NDC:16590-023-15 15 TABLET (TABLET) in 1 BOTTLE None
3 NDC:16590-023-20 20 TABLET (TABLET) in 1 BOTTLE None
4 NDC:16590-023-30 30 TABLET (TABLET) in 1 BOTTLE None
5 NDC:16590-023-40 40 TABLET (TABLET) in 1 BOTTLE None
6 NDC:16590-023-60 60 TABLET (TABLET) in 1 BOTTLE None
7 NDC:16590-023-62 84 TABLET (TABLET) in 1 BOTTLE None
8 NDC:16590-023-72 120 TABLET (TABLET) in 1 BOTTLE None
9 NDC:16590-023-75 75 TABLET (TABLET) in 1 BOTTLE None
10 NDC:16590-023-82 180 TABLET (TABLET) in 1 BOTTLE None
11 NDC:16590-023-90 90 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089805 09/30/1988
Labeler — STAT RX USA LLC (786036330)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 repack, relabel

Revised: 07/2010 STAT RX USA LLC

Page 3 of 3 1 2 3

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.