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, nonsalicylate 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
(Warning: May be habit forming)
In addition the following inactive ingredients are present:
Citric acid, propylene glycol, sodium benzoate, saccharin sodium, sucrose,
artificial cherry flavor, FD and C Yellow No. 6 and purified water.
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: 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.
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.
To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 appreciably 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 in children is 0.5 mg/kg of body weight. The usual doses are:
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Acetaminophen and Codeine Phosphate Oral Solution, USP is an amber colored, cherry flavored syrup containing 120 mg acetaminophen and 12 mg codeine phosphate/5 mL supplied in 16 fl oz bottles.
Store at controlled room temperature 15° to 30°C (59° to 86°F). Do not refrigerate.
Dispense in tight, light-resistant container as defined in the official compendium.
HI-TECH PHARMACAL CO., INC.
Amityville, NY 11701
Rev. 079:03 4/09