Aspirin, Butalbital, and Caffeine
Aspirin, Butalbital, and Caffeine is a combination pain reliever, sedative-type medicine and stimulant used to relieve tension headache.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 6 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Aspirin, butalbital and caffeine (Fiorinal) treats tension headache, with aspirin relieving pain and butalbital, a barbiturate sedative, easing tension and tight muscles; on the market since about 1985 and available as a generic, it is an older standby usually saved for when simpler pain relievers fall short. An occasional dose is usually well tolerated, though drowsiness, dizziness and nausea are common. The thing to watch is how often you take it, because butalbital is habit-forming and it is meant for an occasional headache, not daily or repeated use. Its aspirin also raises bleeding risk, making it a poor fit with ulcers, bleeding disorders, blood thinners or late pregnancy.
Clinical pearls
- Skip alcohol, opioids, sleep aids and anxiety medicines while taking it, since together they can dangerously slow your breathing.
- Avoid adding ibuprofen or naproxen, because stacking another NSAID on its aspirin raises the risk of stomach ulcers and bleeding.
- Tell your surgeon or dentist you take it before any procedure, because the aspirin prolongs bleeding time.
- Stop it and get help at the first rash, blistering, facial swelling or trouble breathing, which can signal a serious reaction.
Patient information guide A plain-language walkthrough of Aspirin, Butalbital, and Caffeine, written from its FDA label.
What Aspirin, Butalbital, and Caffeine is used for
▾
Aspirin, Butalbital, and Caffeine is supported here for one use:
- Butalbital, aspirin, and caffeine oral capsules: relief of the symptom complex of tension (muscle contraction) headache.
It has not been shown to work for multiple recurrent headaches.
How Aspirin, Butalbital, and Caffeine works
▾
Aspirin provides pain relief. Butalbital, a barbiturate, adds calming and muscle-relaxing effects. Caffeine is the third ingredient.
In placebo-controlled trials, the capsules relieved headache pain, mental tension and muscle tightness in the head, neck and shoulders. A study comparing the combination with its components showed each one contributes, and the combination was significantly better than either component alone.
Aspirin, Butalbital, and Caffeine dosage
▾
The capsules are taken by mouth. The label directs one or two capsules about every 4 hours, with no more than 6 in a day.
- Avoid extended or repeated use because of the risk of physical dependence.
- Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Aspirin, Butalbital, and Caffeine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Aspirin, butalbital, and caffeine capsules (no specific condition named)
- One or 2 capsules every 4 hours
- Maximum: Total daily dose should not exceed 6 capsules
- Extended and repeated use is not recommended because of the potential for physical dependence
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION 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.
Read the full Dosage and Administration section on DailyMed →
Aspirin, Butalbital, and Caffeine side effects
▾
The most common side effects are:
Common side effects
- Drowsiness
- Dizziness
- Lightheadedness
- Nausea
- Vomiting
- Gas (flatulence)
When to get medical help
- Get emergency help for signs of a severe allergic reaction, such as trouble breathing or facial swelling.
- Stop the medicine and call your doctor right away at the first sign of a skin rash, blistering or peeling skin.
- Call your doctor right away if you have fever, rash, swollen glands or facial swelling. These can be signs of a serious reaction called DRESS.
- Seek help if you notice unusual bleeding.
- Get urgent help for overdose signs: extreme drowsiness, confusion, slow breathing, ringing in the ears, vomiting, or seizures.
Rarely, serious skin reactions, DRESS and bone marrow suppression have been reported. Stop the medicine and get medical help for a rash, blistering, fever or facial swelling.
Aspirin, Butalbital, and Caffeine warnings and precautions
▾
- Habit-forming: butalbital can be abused and cause physical dependence, so long-term use is not recommended.
- Allergy: aspirin can cause anaphylaxis and other severe allergic reactions.
- Bleeding: risk is higher with ulcers, other stomach lesions or bleeding disorders, and aspirin may prolong bleeding time before surgery.
- Skin reactions and DRESS: can be serious and even fatal, and may occur without warning.
- Reye's Syndrome: use caution in children and teens with chicken pox or flu.
- Pregnancy: NSAIDs can cause fetal heart vessel closure at about 30 weeks or later, and fetal kidney problems with low amniotic fluid from about 20 weeks.
Aspirin, Butalbital, and Caffeine interactions
▾
This medicine can clash with several types of drugs:
- Alcohol, opioids, tranquilizers, sedatives, anesthetics: more drowsiness and CNS depression.
- MAO inhibitors: can enhance butalbital's brain effects.
- Oral blood thinners: more bleeding.
- Insulin and diabetes pills: low blood sugar if the maximum daily amount is exceeded.
- Methotrexate, 6-mercaptopurine: bone marrow toxicity and blood problems.
- Other NSAIDs: more ulcer and bleeding risk.
- Corticosteroids: stopping them during chronic aspirin use may cause salicylism (aspirin toxicity).
- Probenecid, sulfinpyrazone: less effective for gout.
Interactions listed in the FDA-approved label
From the Aspirin, Butalbital, and Caffeine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Monoamine oxidase (MAO) inhibitors: The CNS effects of butalbital may be enhanced by MAO inhibitors.
- Corticosteroids (in patients on chronic aspirin): Withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance.
- Oral anticoagulants: The capsules may enhance their effects, causing bleeding by inhibiting prothrombin formation in the liver and displacing anticoagulants from plasma protein binding sites.
- Oral antidiabetic agents and insulin: The capsules may enhance their effects, causing hypoglycemia by contributing an additive effect, if dosage exceeds maximum recommended daily dosage.
- 6-mercaptopurine and methotrexate: The capsules may enhance their effects, causing bone marrow toxicity and blood dyscrasias by displacing these drugs from secondary binding sites, and, in the case of methotrexate, also reducing its excretion.
- Non-steroidal anti-inflammatory agents: The capsules may enhance their effects, increasing the risk of peptic ulceration and bleeding by contributing additive effects.
- Other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants: The capsules may enhance their effects, causing increased CNS depression.
- Uricosuric agents such as probenecid and sulfinpyrazone: The capsules may diminish their effects, reducing their effectiveness in the treatment of gout; aspirin competes with these agents for protein binding sites.
Read the label’s full interactions text
Drug Interactions The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors. In patients receiving concomitant corticosteroids and chronic use of aspirin, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance. Butalbital, aspirin, and caffeine capsules may enhance the effects of: • Oral anticoagulants, causing bleeding by inhibiting prothrombin formation in the liver and displacing anticoagulants from plasma protein binding sites. • Oral antidiabetic agents and insulin, causing hypoglycemia by contributing an additive effect, if dosage of butalbital, aspirin, and caffeine capsules exceeds maximum recommended daily dosage. • 6-mercaptopurine and methotrexate, causing bone marrow toxicity and blood dyscrasias by displacing these drugs from secondary binding sites, and, in the case of methotrexate, also reducing its excretion. • Non-steroidal anti-inflammatory agents, increasing the risk of peptic ulceration and bleeding by contributing additive effects. • Other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression. Butalbital, aspirin, and caffeine capsules may diminish the effects of: Uricosuric agents such as probenecid and sulfinpyrazone, reducing their effectiveness in the treatment of gout. Aspirin competes with these agents for protein binding sites.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Aspirin, Butalbital, and Caffeine
▾
- Do not use with allergy or intolerance to aspirin, caffeine or butalbital.
- Do not use with bleeding disorders, including severe liver damage.
- Do not use with nasal polyps, angioedema and breathing spasms triggered by aspirin or NSAIDs.
- Do not use with a peptic ulcer or serious stomach or intestinal lesions.
- Do not use with porphyria.
- Be careful in children and teens with chicken pox or flu.
- Pregnancy: avoid at about 30 weeks or later, and limit use from about 20 weeks.
Aspirin, Butalbital, and Caffeine overdose
▾
Overdose is mainly a risk from butalbital and aspirin. Signs can include drowsiness, confusion, coma, slow breathing, low blood pressure, ringing in the ears, vomiting, abdominal pain, fever and seizures. Get emergency help or contact a Poison Control Center right away.
What Aspirin, Butalbital, and Caffeine does in the body
▾
The capsules combine aspirin's pain relief with butalbital's calming and muscle-relaxing effects. Together they relieve headache pain, mental tension and muscle tightness in the head, neck and shoulders.
How your body processes Aspirin, Butalbital, and Caffeine
▾
All three ingredients are absorbed well. Aspirin peaked at about 40 minutes, butalbital at about 1.5 hours, and caffeine in under an hour in the label's studies. Aspirin has a short half-life (about 12 minutes; salicylate about 3 hours), butalbital about 35 hours and caffeine about 3 hours. The ingredients are processed mostly by the liver and cleared by the kidneys.
How to store Aspirin, Butalbital, and Caffeine
▾
Store and Dispense Store at 20° to 25°C (68° to 77°F). Dispense in a tight container as defined in the USP with a child-resistant closure. Protect from moisture.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Aspirin, Butalbital, and Caffeine
347 supplements and herbal products have documented interactions with Aspirin, Butalbital, and Caffeine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 13
- Moderate · 285
- Minor · 49
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Aspirin, Butalbital, and Caffeine has been associated with lower levels of 4 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 2
- Moderate · 2
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Aspirin, Butalbital, and Caffeine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Aspirin, Butalbital, and Caffeine — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
▾
How do I take it?
▾
What side effects should I expect?
▾
Can I drink alcohol with it?
▾
Is it safe in pregnancy?
▾
When should I call my doctor?
▾
Is Aspirin, Butalbital, and Caffeine available over the counter?
▾
Is Aspirin, Butalbital, and Caffeine a controlled substance?
▾
When was Aspirin, Butalbital, and Caffeine first available?
▾
Who makes Aspirin, Butalbital, and Caffeine?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Aspirin, Butalbital, and Caffeine on HelloPharmacist
Aspirin, Butalbital, and Caffeine forms and strengths (how it comes)
Aspirin, Butalbital, and Caffeine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Butalbital, aspirin, and caffeine capsules are used to relieve tension (muscle contraction) headache.
- Butalbital, aspirin, and caffeine capsules are taken by mouth, one or two capsules every 4 hours.
- Butalbital, aspirin, and caffeine capsules should not exceed 6 capsules in a day.
- Extended and repeated use of butalbital, aspirin, and caffeine capsules is not recommended because of the risk of physical dependence.
Aspirin, Butalbital, and Caffeine on the U.S. market: products, makers and brands
How Aspirin, Butalbital, and Caffeine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
5 companies list 5 Aspirin, Butalbital, and Caffeine product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 1985. Brand names on the directory include Fiorinal, Lanorinal, Farbital and 6 more; the rest are generics.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Aspirin, Butalbital, and Caffeine is used (Medicaid data)
A general measure of how commonly Aspirin, Butalbital, and Caffeine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Aspirin, Butalbital, and Caffeine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Aspirin, Butalbital, and Caffeine prescribed? Of the 1,601 medications we measure, Aspirin, Butalbital, and Caffeine ranks #969 by Medicaid prescriptions — more than 39% of them.
Utilization by Aspirin, Butalbital, and Caffeine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
aspirin 325 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule
Summed across the 2 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 238134
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Aspirin, Butalbital, and Caffeine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 10 listed Aspirin, Butalbital, and Caffeine NDCs with Medicaid activity.
Compare Aspirin, Butalbital, and Caffeine products
A representative set of FDA-listed product records for Aspirin, Butalbital, and Caffeine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| BUTALBITAL 50 mg/1; ASPIRIN 325 mg/1; CAFFEINE 40 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ASPIRIN 325 mg/1; CAFFEINE 40 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ASPIRIN 500 mg/1; CAFFEINE 40 mg | Oral | Lgm Pharma Solutions, Llc | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ASPIRIN 325 mg/1; CAFFEINE 40 mg | Oral | Sandoz Inc | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ASPIRIN 325 mg/1; CAFFEINE 40 mg | Oral | Westminster Pharmaceuticals, LLC | ANDA | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Aspirin, Butalbital, and Caffeine NDCs →
Aspirin, Butalbital, and Caffeine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Aspirin, Butalbital, and Caffeine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Aspirin, Butalbital, and Caffeine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Aspirin, Butalbital, and Caffeine FDA approval history
How Aspirin, Butalbital, and Caffeine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Aspirin, Butalbital, and Caffeine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Aspirin, Butalbital, and Caffeine recalls since July 2021.
✅No Aspirin, Butalbital, and Caffeine recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
Aspirin, Butalbital, and Caffeine supply and shortage status
Whether Aspirin, Butalbital, and Caffeine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Aspirin, Butalbital, and Caffeine costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Capsule · Oral | BUTALBITAL 50 mg/1; ASPIRIN 325 mg/1; CAFFEINE 40 mg | $0.948 per capsule | NDC details & price history |
| Capsule · Oral | 325; 50; 40 mg/1; mg/1; mg | $0.948 per capsule | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Aspirin, Butalbital, and Caffeine brand names
Aspirin, Butalbital, and Caffeine is sold under 9 brand names in the FDA directory — Fiorinal, Lanorinal, Farbital, Fiormor and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Aspirin, Butalbital, and Caffeine: manufacturers and labelers
5 companies list Aspirin, Butalbital, and Caffeine products with the FDA. By number of product records, the largest are Chartwell RX, LLC, Lgm Pharma Solutions, Llc, Lannett Company, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Aspirin, Butalbital, and Caffeine drug class (RxNorm)
Aspirin, Butalbital, and Caffeine belongs to the Platelet Aggregation Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Aspirin, Butalbital, and Caffeine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Lgm Pharma Solutions, Llc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →