Fixed-dose combination
Acetaminophen, Butalbital and Caffeine is a fixed-dose combination of a barbiturate, a central nervous system stimulant and a methylxanthine indicated for the relief of the symptom complex of tension (or muscle contraction) headache. MedsAcross supplies Acetaminophen, Butalbital and Caffeine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Butalbital, acetaminophen and caffeine oral solution is 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.
Source: US FDA prescribing information
One or two tablespoonfuls (15 mL or 30 mL) every four hours. Total daily dosage should not exceed 6 tablespoonfuls. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
Source: US FDA prescribing information
This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product. Patients with porphyria.
Source: US FDA prescribing information
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. Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended. 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.
Source: US FDA prescribing information
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 swallowing, heartburn, flatulence, constipation. Cardiovascular: tachycardia. Musculoskeletal: leg pain, muscle fatigue. Genitourinary: diuresis.
Source: US FDA prescribing information
The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors. 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.
Source: US FDA prescribing information
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
5 presentations of Acetaminophen, Butalbital and Caffeine, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Acetaminophen, Butalbital and Caffeine 325 mg/50 mg/40 mg tabletOralGeneric name | Acetaminophen, Butalbital and Caffeine | — | US FDA | Available on request |
| Acetaminophen, Butalbital and Caffeine 300 mg/50 mg/40 mg capsuleOralGeneric name | Acetaminophen, Butalbital and Caffeine | — | US FDA | Available on request |
| Acetaminophen, Butalbital and Caffeine 325 mg/50 mg/40 mg capsuleOralGeneric name | Acetaminophen, Butalbital and Caffeine | — | US FDA | Available on request |
| Acetaminophen, Butalbital and Caffeine 325 mg/50 mg/40 mg per 15 mL oral solutionOralGeneric name | Acetaminophen, Butalbital and Caffeine | — | US FDA | Available on request |
| Fioricet 300 mg/50 mg/40 mg capsuleOral | Acetaminophen, Butalbital and Caffeine | Actavis Pharma | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | Approved | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 5 presentations of Acetaminophen, Butalbital and Caffeine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Acetaminophen, Butalbital and Caffeine, including Fioricet.
No listed presentation of Acetaminophen, Butalbital and Caffeine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.