ACETAMINOPHEN AND CODEINE PHOSPHATE (Page 3 of 3)

Treatment

A single or multiple drug overdose with acetaminophen and codeine is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.

Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered. For respiratory depression due to overdosage or unusual sensitivity to codeine, parenteral naloxone is a specific and effective antagonist.

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to severity of pain and response of the patient.

The usual adult dosage for tablets 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

Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/15 mg tablet contains acetaminophen 300 mg and codeine phosphate 15 mg. It is available as a round, white to off-white tablet debossed with “2” on one side and an Imprint Code on the other side.

Bottles of 100 . . . . . . . NDC 0406-0483-01

Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/30 mg tablet contains acetaminophen 300 mg and codeine phosphate 30 mg. It is available as a round, white to off-white tablet debossed with “3” on one side and an Imprint Code on the other side.

Bottles of 20 . . . . . . . . NDC 0406-0484-20
Bottles of 30 . . . . . . . . NDC 0406-0484-03
Bottles of 50 . . . . . . . . NDC 0406-0484-50
Bottles of 100 . . . . . . . NDC 0406-0484-01
Bottles of 1000 . . . . . . NDC 0406-0484-10
Unit Dose (10 x 10) . . NDC 0406-0484-62

Each Acetaminophen and Codeine Phosphate Tablet USP 300 mg/60 mg tablet contains acetaminophen 300 mg and codeine phosphate 60 mg. It is available as a round, white to off-white tablet debossed with “4” on one side and an Imprint Code on the other side.

Bottles of 100 . . . . . . . NDC 0406-0485-01
Bottles of 500 . . . . . . . NDC 0406-0485-05

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

Dispense in tight, light-resistant container as defined in the USP.

Imprint Code is a trademark of Mallinckrodt Inc.

Mallinckrodt Inc.
Hazelwood, MO 63042 USA

Rev 06/2011

Mallinckrodt COVIDIEN™

PRINCIPAL DISPLAY PANEL

NDC 55045-1580-05
(click image for full-size original)

NDC 55045-1580-05

15 TABLETS

ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP

CIII

300 mg/15 mg

Rx only
Each tablet contains:
Acetaminophen USP . . . . . . . . . . . . . . . 300 mg
Codeine Phosphate USP. . . . . . . . . . . . . 15 mg

This package is not for household use.

ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen and codeine phosphate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55045-1580(NDC:0406-0483)
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 15 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white (to off-white) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 2;M
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55045-1580-5 15 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040419 07/06/2011
Labeler — Dispensing Solutions, Inc. (066070785)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 relabel, repack

Revised: 09/2011 Dispensing Solutions, Inc.

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