displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Acetaminophen and codeine phosphate oral solution is pharmacologically classified as an analgesic.
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 5 mL, for oral administration, contains:
INACTIVE INGREDIENTS: FD&C Red No. 40, FD&C Yellow No. 6 (Sunset Yellow), flavoring, glycerin, propylene glycol, purified water, sodium saccharin, and sucrose.
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 & USAGE SECTION
FDA Article Code: 34067-9
Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate 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: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The most frequently reported adverse reactions are drowsiness, light-headedness, 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, pruritis, 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 & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind 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 appreciable increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.
Acetaminophen and codeine phosphate oral solution contains 120 mg of acetaminophen and 12 mg of codeine phosphate per 5 mL (teaspoonful) and is given orally.
The recommended dose of codeine phosphate for children is 0.5 mg/kg body weight. The usual doses are:
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Acetaminophen and Codeine Phosphate Oral Solution USP (orange-yellow color, cherry flavor) is supplied in the following oral dosage forms: NDC 0121-0504-04 (4 fl. oz. bottles), NDC 0121-0504-16 (16 fl. oz. bottles), NDC 0121-0504-05 (unit dose cups of 5 mL, 10 × 10’s), NDC 0121-0504-10 (unit dose cups of 10 mL, 10 × 10’s), NDC 0121-0504-12 (unit dose cups of 12.5 mL, 10 × 10’s), and NDC 0121-0504-15 (unit dose cups of 15 mL, 10 × 10’s).
PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
ORAL SOLUTION USP
5 UNIT DOSE CUPS