ACETAMINOPHEN AND CODEINE PHOSPHATE (Page 3 of 3)

DRUG ABUSE AND DEPENDENCE

Controlled Substance

Acetaminophen and codeine phosphate tablets are classified as a Schedule III controlled substance.

Abuse and Dependence

Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

OVERDOSAGE

Following an acute overdosage, toxicity may result from codeine or acetaminophen.

Signs and Symptoms

Toxicity from codeine poisoning includes the opioid triad of pinpoint pupils, depression of respiration, and loss of consciousness. Convulsions may occur.

In acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

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 or more hours 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 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

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/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 M on the other side.
Bottles of 20……………………………NDC 63187-106-20

Bottles of 30……………………………………. NDC 63187-106-30

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.

Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and M are trademarks of a Mallinckrodt company.

© 2013 Mallinckrodt.

Mallinckrodt Inc.
Hazelwood, MO 63042 USA

Rev 10/2013

Mallinckrodt™
Pharmaceuticals

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL

63187-106-20
(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:63187-106(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:63187-106-30 30 TABLET in 1 BOTTLE None
2 NDC:63187-106-20 20 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040419 07/06/2011
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (63187-106), RELABEL (63187-106)

Revised: 01/2021 Proficient Rx LP

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