Prescription medicine
Acetaminophen and butalbital and caffeine Brand names: Fioricet, Butal
Acetaminophen and butalbital and caffeine (Fioricet) is a prescription medicine. FDA's NDC Directory lists it from 35 generic labelers, and pharmacies paid $0.122 per butalbital-acetaminophen-caffeine 50-325-40 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule III
Check it at the source: the acetaminophen and butalbital and caffeine FDA label on DailyMed (effective August 5, 2024, Lannett Company, Inc.); every acetaminophen and butalbital and caffeine label on DailyMed.
Highlights of the record
FDA label of August 5, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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.
Used for
From the label: indications and usageButalbital, acetaminophen, and caffeine tablets, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Forms and strengths
- 50 mg / 325 mg / 40 mg
- 50 mg / 300 mg / 40 mg
- 50 mg/15ml / 325 mg/15ml / 40 mg/15ml
- 50 mg / 40 mg / 325 mg
- 300 mg / 40 mg / 50 mg
- 325 mg / 50 mg / 40 mg
Tablet; capsule; solution.
On the market
- Generic approvals
- 46 first November 9, 1984; 21 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 35 of which 35 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.122 per tablet Butalbital-acetaminophen-caffeine 50-325-40 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest September 28, 2021; 1 more by firms not listed as its makers
- FAERS reports
- 10,624 through July 30, 2026
What is acetaminophen and butalbital and caffeine used for?
From the label: indications and usageButalbital, acetaminophen, and caffeine tablets, 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.
FDA pharmacologic class: Barbiturate, Central Nervous System Stimulant and Methylxanthine.
Source: FDA drug label (Butalbital, Acetaminophen, and Caffeine), Lannett Company, Inc., effective August 5, 2024 (SPL set 42594152-563e-4984-9901-d6ef3b8a6941), via openFDA; the full label on DailyMed
Is there a generic for acetaminophen and butalbital and caffeine (Fioricet)?
The FDA approved the first generic acetaminophen and butalbital and caffeine on November 9, 1984. 46 generic applications are approved; 21 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists acetaminophen and butalbital and caffeine from 35 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for acetaminophen and butalbital and caffeine (Fioricet)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.122 per Butalbital-acetaminophen-caffeine 50-325-40 mg tablet, down 11% from $0.138 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Butalbital-acetaminophen-caffeine 50-325-40 mg tablet (generic)
- Fioricet 50-300-40 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Butalbital-acetaminophen-caffeine 50-300-40 mg capsule | Generic | $0.316 per capsule | $9.49 | -20% |
| Butalbital-acetaminophen-caffeine 50-325-40 mg capsule | Generic | $1.93 per capsule | $57.94 | -16% |
| Butalbital-acetaminophen-caffeine 50-325-40 mg tablet | Generic | $0.122 per tablet | $3.67 | -11% |
| Fioricet 50-300-40 mg capsule | Brand | $8.82 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $264.71 | +9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has acetaminophen and butalbital and caffeine been recalled?
The FDA's Enforcement Report lists 3 recalls naming acetaminophen and butalbital and caffeine since 2013: 0 Class I (the most serious), 1 Class II, 2 Class III; 2 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of acetaminophen and butalbital and caffeine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 28, 2021 | Class III | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals | Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg may have potentially been mislabeled as the following drug: ASPIRIN … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the acetaminophen and butalbital and caffeine label say about other medicines?
The acetaminophen and butalbital and caffeine label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Chlordiazepoxide | drug interactions | Butalbital, acetaminophen, and caffeine may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression. |
Check acetaminophen and butalbital and caffeine against other medicines
Source: FDA drug label (Butalbital, Acetaminophen, and Caffeine), Lannett Company, Inc., effective August 5, 2024 (SPL set 42594152-563e-4984-9901-d6ef3b8a6941), via openFDA; the full label on DailyMed
What do FAERS reports show for acetaminophen and butalbital and caffeine?
The FDA Adverse Event Reporting System holds 10,624 reports that list acetaminophen and butalbital and caffeine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 726 are coded as a death and 2,688 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other barbiturates
- the pharmacologic class, with prices and generics
- Acetaminophen and butalbital and caffeine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other