BUTALBITAL AND ACETAMINOPHEN
Details
- Status
- Prescription
- First Approved
- 1984-10-19
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
Companies
BUTALBITAL AND ACETAMINOPHEN Approval History
What BUTALBITAL AND ACETAMINOPHEN Treats
1 indicationsBUTALBITAL AND ACETAMINOPHEN is approved for 1 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tension Headache
BUTALBITAL AND ACETAMINOPHEN Boxed Warning
WARNING 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....
WARNING 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.
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BUTALBITAL AND ACETAMINOPHEN FDA Label Details
ProIndications & Usage
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.
WARNING 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 a...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.