BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE
Details
- Status
- Prescription
- First Approved
- 2003-08-21
- Routes
- Oral
- Dosage Forms
- Capsule
Companies
BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE Approval History
What BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE Treats
1 indicationsBUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE is approved for 1 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tension Headache
BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE 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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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
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; CAFFEINE; CODEINE FDA Label Details
ProIndications & Usage
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.