Prescription Drug Name:

Acetaminophen and Codeine Phosphate






id: F439F352-A234-8DD9-6C3A-B60954BE39BD
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:
Acetaminophen                      120 mg
Codeine Phosphate                12 mg
Alcohol                                    7%


id: 892F291B-71B3-9D25-857D-14BB528A9387
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.


id: C7B90428-11B7-E707-CEB2-0ED5B8C40874
displayName: INDICATIONS AND USAGE section
FDA Article Code: 34067-9

Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain.


id: 5B397406-B3B5-4A2F-A492-3F8765B9875F
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.


id: AB8E2EC8-B9E2-71EC-E228-AE6CCC1B478D
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.


id: 19EC3B07-DC40-E546-C999-EC89E33754AB
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.


id: 7DE02DFF-0FF5-1042-CB5F-9C0BA64229AC
displayName: OVERDOSAGE section
FDA Article Code: 34088-5

Following an acute overdosage, toxicity may result from codeine or acetaminophen.


id: ADD09AD4-1F9B-78B1-279A-16B3CD563435
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:


id: 6F10B2F4-68BB-3467-D2B6-F293E3834691
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 x 10’s), NDC 0121-0504-10 (unit dose cups of 10 mL, 10 x 10’s), NDC 0121-0504-12 (unit dose cups of 12.5 mL, 10 x 10’s), and NDC 0121-0504-15 (unit dose cups of 15 mL, 10 x 10’s).


id: CF8F6B78-A632-82B1-2C1F-FCE6670F836C
displayName: STORAGE AND HANDLING section
FDA Article Code: 44425-7

Keep tightly closed. Store at controlled room temperature 15°-30°C (59°-86°F). Protect from light.Manufactured By:Pharmaceutical Associates, Inc.Greenville, SC 29605R08/02