BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Details
- Status
- Prescription
- First Approved
- 1984-11-09
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET, SOLUTION
Companies
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE Approval History
What BUTALBITAL, ACETAMINOPHEN AND CAFFEINE Treats
1 indicationsBUTALBITAL, ACETAMINOPHEN AND CAFFEINE 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, ACETAMINOPHEN AND CAFFEINE Boxed 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....
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, ACETAMINOPHEN AND CAFFEINE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Butalbital, Acetaminophen, and Caffeine capsules, USP 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.
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 acetamino...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.