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Side Effects & Adverse Reactions
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.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain.
History
There is currently no drug history available for this drug.
Other Information
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%
Glycerin, propylene glycol, sodium saccharin, and sucrose, NF. Also FD&C Red No. 40, FD&C Yellow No. 6 (Sunset Yellow), flavoring, and purified water USP.
Sources
Acetaminophen And Codeine Solution Manufacturers
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Pd-rx Pharmaceuticals, Inc.
Acetaminophen And Codeine Solution | Pd-rx Pharmaceuticals, Inc.
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.
Adults15 mL (1 tablespoonful) every 4 hours as needed.
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