DESCRIPTION
id: a7b088d1-f1d5-4dc7-bac6-441b9ab75f97
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 M.W. 151.16
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:
C18H21NO3•H3PO4•1/2H2O M.W. 406.37
Each tablet contains:
acetaminophen………………………300 mg
codeine phosphate…………………..15 mg
(Warning: May be habit forming)
OR
acetaminophen………………………300 mg
codeine phosphate………………….. 30 mg
(Warning: May be habit forming)
OR
acetaminophen………………………300 mg
codeine phosphate………………….. 60 mg
(Warning: May be habit forming)
In addition, each tablet contains the following inactive ingredients: corn starch, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The 300 mg/60 mg strength tablets also contain crospovidone, povidone, pregelatinized starch, and stearic acid.
CLINICAL PHARMACOLOGY
id: 4586f0ba-8dcc-4e21-9f94-f437de244d07
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: bfbf04cf-ae99-4f5f-a2ca-63773216b8de
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: 009fa3df-c8b6-400d-bf4f-c60f2f24136d
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: 74eb341e-df48-4275-b007-6d566b77cad3
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.
ADVERSE REACTIONS
id: a3a71e1b-0e41-4de4-bb37-1706c4d4fddc
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: ac8569b3-172d-4220-8194-a29668057f18
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Following an acute overdosage, toxicity may result from codeine or acetaminophen.
DOSAGE AND ADMINISTRATION
id: e278ba23-5828-40b3-9d70-359c885d73cf
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: 290ae2a1-418f-4b60-b740-cc168654ec77
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Acetaminophen and codeine phosphate tablets USP (white, round, unscored):
List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”- “350” on the other side of tablet is available in bottles of 60 tablets.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.
PROTECT FROM LIGHT
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
TEVA PHARMACEUTICALS
USA
Sellersville, PA 18960
Rev. AD 6/2011
Repackaged by:
REBEL DISTRIBUTORS CORP
Thousand Oaks, CA 91320
PRINCIPAL DISPLAY PANEL
id: da5484d4-1a1c-477f-9e0d-5f88358f0c69
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
