BUTALBITAL AND ACETAMINOPHEN Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
BUTALBITAL AND ACETAMINOPHEN is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Butalbital and acetaminophen tablets 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.
What should I know before taking it?
This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product.Patients with porphyria
What important warnings are listed?
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.
How is this medication usually taken?
50 mg/325 mg: One to two tablets every four hours as needed. Total daily dosage should not exceed six tablets. 50 mg/300 mg : One or two tablets every four hours. Total daily dosage should not exceed six tablets. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
What side effects are listed?
Frequently Observed: The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling. Infrequently Observed: All adverse events tabulated below are classified as infrequent. Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital. Autonomic Nervous System: dry mouth, hyperhidrosis. Gastrointestinal: difficulty.
What interactions are listed?
The FDA/DailyMed label should be reviewed for complete details.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0a8a6a16-b23f-45d2-b5d4-540264e74d14
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.