Fioricet® products contain 300 mg of acetaminophen.
Fioricet® products containing 325 mg of acetaminophen have been discontinued.
Be sure to write for Fioricet®
and Fioricet® with Codeine
with 300 mg of acetaminophen
About the formulation
- Fioricet® and Fioricet® with Codeine contain 300 mg of acetaminophen per capsule, replacing the Fioricet® tablets and Fioricet® with Codeine capsules containing the 325 mg dose of acetaminophen
- Change was made in response to a Food and Drug Administration (FDA) guideline recommending acetaminophen dose in prescription medications be limited1
- Fioricet® and Fioricet® with Codeine containing the 325 mg dose of acetaminophen are now discontinued
Contains 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine.2
- The FDA has designated Fioricet® with 300 mg of acetaminophen as having the same therapeutic effect as the discontinued product, which contained 325 mg of acetaminophen3
- Fioricet® has received exempted prescription drug status from the DEA and is no longer regulated as a CIII product3
Fioricet® with Codeine
Contains 50 mg butalbital, 300 mg acetaminophen, 40 mg caffeine, and 30 mg codeine phosphate.4
- The FDA has designated Fioricet® with Codeine with 300 mg of acetaminophen as having the same therapeutic effect as the discontinued product, which contained 325 mg of acetaminophen3
Fioricet® and Fioricet® with Codeine Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headaches. Evidence supporting the efficacy and safety of Fioricet® and Fioricet® with Codeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital and codeine are habit-forming and potentially abusable.
Important Safety Information
Acetaminophen has been associated with cases of acute liver failure, at times requiring liver transplant or resulting in 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. Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism. Fioricet® is contraindicated in patients with hypersensitivity or intolerance to any component of the product and patients with porphyria. Fioricet® with Codeine is contraindicated in postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy, patients with hypersensitivity or intolerance to acetaminophen, caffeine, butalbital, or codeine, and patients with porphyria.
Butalbital and codeine are both habit-forming and potentially abusable. Consequently, the extended use of these combination products is not recommended. Fioricet® and Fioricet® with Codeine should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions. Rarely, acetaminophen can cause serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Additionally, Fioricet® with Codeine should be prescribed with caution in certain special-risk patients, such as those with head injuries, elevated intracranial pressure, hypothyroidism, urethral stricture, Addison’s disease, or prostatic hypertrophy. Safety and effectiveness in pediatric patients below the age of 12 taking Fioricet® have not been established. Safety and effectiveness in pediatric patients taking Fioricet® with Codeine have not been established.
The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.
To report side effects of prescription drugs to the FDA, visit fda.gov/medwatch or call 1-800-FDA-1088.
For more information about Fioricet® or Fioricet® with Codeine please call 1-800-272-5525, see full Fioricet® Prescribing Information, or see full Fioricet® with Codeine Prescribing Information, including the Boxed Warning.
References: 1. Food and Drug Administration. FDA drug safety communication: prescription acetaminophen products to be limited to 325 mg per dosage unit; boxed warning will highlight potential for severe liver failure. http://www.fda.gov/Drugs/DrugSafety/ucm239821.htm. Accessed April 29, 2013. 2. Fioricet® full Prescribing Information. Watson Pharma, Inc. August 2013. 3. Data on File. Watson Laboratories, Inc. 4. Fioricet® with Codeine full Prescribing Information. Watson Pharma, Inc. August 2013.