Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Acetaminophen and Codeine Phosphate Oral Solution USP (orange-yellow color, cherry flavor) is supplied in the following oral dosage forms: NDC 63187-291-04 (4 fl. oz. bottles) STORAGE Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.; PRINCIPAL DISPLAY PANEL A CETAMINOPHEN and C ODEINE P HOSPHATE O RAL S OLUTION USP CV Each 5 mL contains: Acetaminophen 120 mg, Codeine Phosphate 12 mg and Alcohol 7% Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT A05040500 63187-291-04
- HOW SUPPLIED Acetaminophen and Codeine Phosphate Oral Solution USP (orange-yellow color, cherry flavor) is supplied in the following oral dosage forms: NDC 63187-291-04 (4 fl. oz. bottles) STORAGE Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.
- PRINCIPAL DISPLAY PANEL A CETAMINOPHEN and C ODEINE P HOSPHATE O RAL S OLUTION USP CV Each 5 mL contains: Acetaminophen 120 mg, Codeine Phosphate 12 mg and Alcohol 7% Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT A05040500 63187-291-04
Overview
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% INACTIVE INGREDIENTS: FD&C Red No. 40, FD&C Yellow No. 6 (Sunset Yellow), flavoring, glycerin, propylene glycol, purified water, sodium saccharin, and sucrose. Chemical Structure Chemical Structure
Indications & Usage
Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain.
Dosage & Administration
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: Children (7 to 12 years): 10 mL (2 teaspoonfuls) 3 or 4 times daily. (3 to 6 years): 5 mL (1 teaspoonful) 3 or 4 times daily. (under 3 years): safe dosage has not been established. Adults 15 mL (1 tablespoonful) every 4 hours as needed.
Warnings & Precautions
WARNINGS Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well. Hypersensitivity/Anaphylaxis There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue acetaminophen and codeine phosphate oral solution immediately and seek medical care if they experience these symptoms. Do not prescribe acetaminophen and codeine phosphate oral solution for patients with acetaminophen allergy. 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.
Boxed Warning
Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
Contraindications
This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.
Adverse Reactions
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.
Drug Interactions
This drug may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics or other CNS depressants, causing increased CNS depression.
Storage & Handling
STORAGE Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.
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