Acetaminophen & Codeine Phosphate Tablets, USP CIII 300/30 mg
This information is intended for U.S. healthcare professionals only.
Acetaminophen and Codeine Phosphate Tablets, USP (CIII) are indicated for the relief of mild to moderately severe pain.
IMPORTANT RISK INFORMATION
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.
Acetaminophen and codeine phosphate tablets are contraindicated patients who have previously exhibited hypersensitivity to codeine or acetaminophen.
WARNINGS AND PRECAUTIONS
- Respiratory depression is the chief hazard from all opioid agonist preparations. In some patients, usual therapeutic doses of opioids may cause respiratory depression. Patients with pulmonary conditions and pre-existing respiratory depression are at the highest risk.
- There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen.
- Codeine is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
- 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.
- Opioid analgesics should be used with caution when combined with CNS depressant drugs.
- Patients who are CYP2D6 ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing due to rapid conversion of codeine to morphine.
- Serious adverse reactions: respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock.
- Common adverse reactions: lightheadedness, dizziness, sedation, nausea and vomiting, euphoria, dysphoria, constipation, skin rash, and pruritus.
USE IN SPECIFIC POPULATIONS
- Pregnancy: Use of narcotics during pregnancy may produce physical dependence in the neonate.
||Tylenol® with Codeine
||Debossed "3" on one side and an "M" in a box on reverse side
||100 UD (10 x 10)
For additional information on Acetaminophen & Codeine Phosphate Tablets, USP CIII 300/30 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.
Tylenol is a registered trademark of The Tylenol Company.