displayName: Description section
FDA Article Code: 34089-3
Acetaminophen and codeine 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:C8H9NO2 MW = 151.16Codeine phosphate, 7,8-didehydro-4, 5 α-epoxy-3-methoxy-17-methylmorphinan-6 α-ol phosphate (1:1)(salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:C18H21NO3•H3PO4•½H2O MW = 406.37Each tablet contains:Acetaminophen…………………………………..650 mg
Codeine Phosphate………………………………60 mg(Warning: May be habit forming)In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid.
displayName: Clinical Pharmacology section
FDA Article Code: 34090-1
This product combines the analgesic effects of a centrally acting analgesic, codeine, with a peripherally acting analgesic, acetaminophen.
INDICATIONS AND USAGE
displayName: Indications and Usage section
FDA Article Code: 34067-9
Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.
displayName: Contraindications section
FDA Article Code: 34070-3
This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.
displayName: Warnings section
FDA Article Code: 34071-1
In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of the patients with head injuries.Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.Codeine is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
displayName: Adverse Reactions section
FDA Article Code: 34084-4
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.
displayName: Overdosage section
FDA Article Code: 34088-5
Following an acute overdosage, toxicity may result from codeine or acetaminophen.
DOSAGE AND ADMINISTRATION
displayName: Dosage and Administration section
FDA Article Code: 34068-7
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 DoseCodeine Phosphate 15 mg to 60 mg 360 mgAcetaminophen 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.
displayName: How Supplied section
FDA Article Code: 34069-5
Acetaminophen and Codeine Phosphate Tablets USP, 650 mg/60 mg are available as a capsule-shaped, white, uncoated, unprinted tablet single-scored on one side, in bottles of 100,NDC 0785-6270-01 and in bottles of 500, NDC 0785-6270-50.