DESCRIPTION
id: 19765b52-4079-4930-9742-e303417df9ce
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:
Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:
Each 300 mg/30 mg Acetaminophen and Codeine Phosphate Tablet contains:
Acetaminophen …………………………………………………………………………………………300 mg
Codeine Phosphate ……………………………………………………………………………………..30 mg
Each 300 mg/60 mg Acetaminophen and Codeine Phosphate Tablet contains:
Acetaminophen …………………………………………………………………………………………300 mg
Codeine Phosphate ……………………………………………………………………………………..60 mg
CLINICAL PHARMACOLOGY
id: 5df27394-da47-450e-b8d4-bd3bb55ff61a
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
id: 5596c343-49a1-74c1-e900-3cb1710946a0
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.
CONTRAINDICATIONS
id: 22ed01e4-2ed5-c157-94c0-6c878cb3389c
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.
WARNINGS
id: 19b9c0fd-50ab-5ae1-cde2-7f04ae3315a3
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.
Acetaminophen and codeine phosphate tablets contain sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
ADVERSE REACTIONS
id: 123703c9-2be0-3339-133f-61d548156eab
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.
OVERDOSAGE
id: 8d4f0b33-a4b1-41ab-8013-d232754534e0
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Following an acute overdosage, toxicity may result from codeine or acetaminophen.
DOSAGE AND ADMINISTRATION
id: ea2df826-f170-4d3e-acea-bb0f938e7cc5
displayName: DOSAGE & 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 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
id: 3a0cee7c-fd12-470c-8f52-ce86a044e74c
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
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.
PRINCIPAL DISPLAY PANEL
id: bda82fcb-c05d-4c58-bc07-c08d4ff593e2
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
APAP-CODEINE 300-30MG LABEL IMAGE
