Cocet Plus Recall
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Questions & Answers
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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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.
Cocet Plus (acetaminophen and codeine phosphate tablets) is indicated for the relief of mild to moderately severe pain.
There is currently no drug history available for this drug.
Acetaminophen and codeine phosphate are supplied in tablet form for oral administration.
Acetaminophen, 4’-hydroxy-acetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
C8H9NO2 M.W. 151.16
Codeine phosphate occurs as fine, white, needle-shaped crystals, or white, crystalline powder, is a narcotic analgesic and antitussive. Its chemical name is: 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. It has the following structural formula:
C18H21NO3 · H3PO4 · 1/2 H2O
Each tablet for oral administration, contains acetaminophen and codeine phosphate in the following strengths:
Acetaminophen.............................……. 650 mg
Codeine Phosphate.......................……. 60 mg
(Warning: May be habit-forming)
In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, , crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid.