Fixed-dose combination
Aspirin, 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 Aspirin, 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, aspirin, and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, aspirin, and caffeine capsules 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 2 capsules every 4 hours. Total daily dose should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
Source: US FDA prescribing information
Butalbital, aspirin, and caffeine capsules are contraindicated under the following conditions: Hypersensitivity or intolerance to aspirin, caffeine, or butalbital. Patients with a hemorrhagic diathesis (e.g., hemophilia, hypoprothrombinemia, von Willebrand's disease, the thrombocytopenias, thrombasthenia and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency and severe liver damage). Patients with the syndrome of nasal polyps, angioedema and bronchospastic reactivity to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylactoid reactions have occurred in such patients. Peptic ulcer or other serious gastrointestinal lesions. Patients with porphyria.
Source: US FDA prescribing information
Therapeutic doses of aspirin can cause anaphylactic shock and other severe allergic reactions. It should be ascertained if the patient is allergic to aspirin, although a specific history of allergy may be lacking. Significant bleeding can result from aspirin therapy in patients with peptic ulcer or other gastrointestinal lesions, and in patients with bleeding disorders. Aspirin administered preoperatively may prolong the bleeding time. Butalbital is habit-forming and potentially abusable. Consequently, the extended use of butalbital, aspirin, and caffeine capsules is not recommended. Results from epidemiologic studies indicate an association between aspirin and Reye's Syndrome. Caution should be used in administering this product to children, including teenagers, with chicken pox or flu.
Source: US FDA prescribing information
The most frequent adverse reactions are drowsiness and dizziness. Less frequent adverse reactions are lightheadedness and gastrointestinal disturbances including nausea, vomiting, and flatulence. A single incidence of bone marrow suppression has been reported with the use of butalbital, aspirin, and caffeine capsules. Several cases of dermatological reactions including toxic epidermal necrolysis and erythema multiforme have been reported.
Source: US FDA prescribing information
Store at 20° to 25°C (68° to 77°F). Protect from moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Aspirin, Butalbital and Caffeine, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Aspirin, Butalbital and Caffeine 325 mg/50 mg/40 mg capsuleOralGeneric name | Aspirin, Butalbital and Caffeine | — | US FDA | Available on request |
| Aspirin, Butalbital and Caffeine 500 mg/50 mg/40 mg capsuleOralGeneric name | Aspirin, Butalbital and Caffeine | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 4 May 1976 | 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 2 presentations of Aspirin, Butalbital and Caffeine and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Aspirin, Butalbital and Caffeine on 4 May 1976, according to Drugs@FDA.
No listed presentation of Aspirin, Butalbital and Caffeine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
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