Butalbital and Acetaminophen Capsules

Mayne Pharma now has Butalbital/Acetaminophen

50mg/300mg 100 count Capsules

 

Ask your wholesaler today for more information.

NDC#51862-544-01

To locate full prescribing information, please click here.

 

Also available – Co-Pay Savings Card

* Most eligible patients pay $0.

* Out of pocket costs may vary.

To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

 

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IMPORTANT SAFETY INFORMATION

HEPATOTOXICITY

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.

Butalbital and Acetaminophen Capsules Indication and Usage

Butalbital and acetaminophen capsules 50 mg/300 mg are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

Selected Safety Information about Butalbital and Acetaminophen Capsules.

  • Butalbital and acetaminophen capsules 50 mg/300 mg are contraindicated in patients who have shown hypersensitivity or intolerance to any component of this product and patients with porphyria.
  • Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
  • Hepatotoxicity: 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. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
  • Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Full prescribing information, including warnings, can be found here.
  • Butalbital and acetaminophen capsules 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.
  • The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.

To report a suspected adverse reaction from one of our products, please contact Mayne Pharma at 1-844-8500 or maynepharmamc@dlss.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.