Drug Facts
Composition & Profile
Identifiers & Packaging
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 M on the other side. 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. 49999-060-06 49999-060-15 49999-060-12 49999-060-10 49999-060-20 49999-060-24 49999-060-30 49999-060-50 49999-060-60 49999-060-90 49999-060-00 49999-060-01 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 M on the other side. 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. is a trademark of Mallinckrodt Inc. Mallinckrodt Inc. Hazelwood, MO 63042 USA Rev 06/2011 Mallinckrodt COVIDIEN™ Imprint Code; image description
- 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 M on the other side. 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. 49999-060-06 49999-060-15 49999-060-12 49999-060-10 49999-060-20 49999-060-24 49999-060-30 49999-060-50 49999-060-60 49999-060-90 49999-060-00 49999-060-01 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 M on the other side. 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. is a trademark of Mallinckrodt Inc. Mallinckrodt Inc. Hazelwood, MO 63042 USA Rev 06/2011 Mallinckrodt COVIDIEN™ Imprint Code
- image description
Overview
Acetaminophen and codeine phosphate is supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains: Acetaminophen USP . . . . . . . . . . . . . 300 mgCodeine Phosphate USP . . . . . . . . . . . . . 30 mg Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains: Acetaminophen USP . . . . . . . . . . . . . 300 mgCodeine Phosphate USP . . . . . . . . . . . . . 60 mg In addition, each Acetaminophen and Codeine Phosphate Tablet USP contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid. Acetaminophen Chemical Structure Codeine Phosphate Chemical Structure
Indications & Usage
Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.
Dosage & 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.
Warnings & Precautions
WARNINGS
Boxed Warning
Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
Contraindications
This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.
Adverse Reactions
The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus, rash, thrombocytopenia, agranulocytosis. At higher doses, codeine has most of the disadvantages of morphine including respiratory depression.
Drug Interactions
This drug may enhance the effects of other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.
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