Acetaminophen, Butalbital, and Caffeine
A combination of butalbital, acetaminophen, and caffeine used to relieve tension headaches across multiple oral products.
🧬 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 73 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 →
Acetaminophen, butalbital, and caffeine (best known as Fioricet) treats tension headaches by pairing a pain reliever with a barbiturate sedative and caffeine, which is thought to boost the relief; on the market since about 1987 and available generically, it is an older standby, usually not a first choice. Most people tolerate it well, though drowsiness, dizziness and a sluggish, tipsy feeling are common. The thing to watch is the boxed warning for serious liver damage from the acetaminophen, most likely when you exceed the daily limit, drink alcohol or add Tylenol or another APAP product. Butalbital is habit-forming, so save it for occasional headaches.
Clinical pearls
- Combining it with sleep aids, tranquilizers or opioid pain relievers can dangerously deepen drowsiness and slow your breathing.
- MAO inhibitors, an older class of antidepressants, can strengthen butalbital's sedation, so that pairing should be avoided.
- Tell your surgeon and anesthesia team you take it, because general anesthetics can act more strongly than expected.
- If you find yourself reaching for it most weeks, ask your prescriber about prevention, since frequent use can itself cause more headaches.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Risk of serious liver damage: Acetaminophen — one of the ingredients in this product — has been linked to cases of acute (sudden) liver failure, sometimes requiring a liver transplant or resulting in death. This risk is greatest when acetaminophen is taken at doses exceeding 4,000 milligrams per day, and is especially dangerous when more than one acetaminophen-containing product is used at the same time. Always check the labels of all your medications for acetaminophen or APAP, and seek medical attention immediately if you think you have taken too much — even if you feel well.
Patient information guide A plain-language walkthrough of Acetaminophen, Butalbital, and Caffeine, written from its FDA label.
What Acetaminophen, Butalbital, and Caffeine is used for
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Acetaminophen, butalbital, and caffeine is a prescription combination product used to relieve tension headaches. All supported products share this indication:
- Fioricet capsules are indicated for the relief of tension (muscle contraction) headache symptoms
- Butalbital, Acetaminophen and Caffeine capsules are indicated for the relief of tension headache symptoms
- Butalbital, Acetaminophen and Caffeine tablets are indicated for the relief of tension headache symptoms
- Butalbital, Acetaminophen and Caffeine oral solution is indicated for the relief of tension headache symptoms
- Note: none of these products have established evidence for treating frequent, recurring headaches — and because butalbital is habit-forming, extended use is not recommended regardless of product or form
How Acetaminophen, Butalbital, and Caffeine works
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This combination product is intended to treat tension headache, though exactly how all three ingredients work together is not fully understood. Butalbital is a barbiturate — a type of sedative — that reduces tension and anxiety. Acetaminophen works as a pain reliever and mild fever reducer. Caffeine is included because xanthines like caffeine are thought to enhance the pain-relieving effects of the other ingredients.
Acetaminophen, Butalbital, and Caffeine dosage
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This medication is taken by mouth as needed when a tension headache occurs. Capsule and tablet forms are generally taken every four hours as needed, and the oral solution is measured in tablespoonfuls taken every four hours. Regardless of form, the total daily dose must not exceed six units (capsules, tablets, or tablespoonfuls) per day. Extended or repeated use is not recommended because of the risk of physical dependence from butalbital. Always follow the instructions your prescriber and pharmacist have given you — do not take more than directed.
Dosing details from the FDA-approved label
From the Acetaminophen, 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.
- Butalbital, Acetaminophen, and Caffeine tablets
- One or 2 tablets every 4 hours as needed
- Maximum: Total daily dosage should not exceed 6 tablets
- Extended and repeated use is not recommended because of the potential for physical dependence
- Butalbital, Acetaminophen and Caffeine oral solution
- One or two tablespoonfuls (15 mL or 30 mL) every four hours
- Maximum: Total daily dosage should not exceed 6 tablespoonfuls
- Extended and repeated use is not recommended because of the potential for physical dependence
- Butalbital, Acetaminophen, and Caffeine capsules
- One or two capsules every four hours as needed (1 or 2 capsules every 4 hours as needed)
- Maximum: Total daily dosage 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 two tablets every four hours as needed. Total daily dosage should not exceed 6 tablets. 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 →
Acetaminophen, Butalbital, and Caffeine side effects
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The most common side effects people notice include:
Common side effects
- Drowsiness or sedation
- Dizziness or lightheadedness
- Nausea or vomiting
- Abdominal pain
- Shortness of breath
- Feeling intoxicated or sluggish
- Dry mouth
- Constipation
- Constipation or flatulence
- Shaky feeling or tingling
When to get medical help
- Get emergency help immediately if you take more than the maximum daily amount of acetaminophen — even if you feel fine
- Seek medical care right away if you notice yellowing of the skin or eyes, severe stomach pain, or unusual fatigue — these can be signs of liver damage
- Stop taking this medication and get emergency help if you develop swelling of the face, mouth, or throat, trouble breathing, or severe rash — signs of a serious allergic reaction (anaphylaxis)
- Stop taking it and contact your doctor at the first sign of any new skin rash — rarely, acetaminophen can cause life-threatening skin reactions
- Call your doctor if you notice signs of confusion, excitement, or depression — especially if you are elderly or have been taking high doses
- Call Poison Control (1-800-222-1222) immediately in case of overdose
More serious reactions — including confusion or mental changes (especially in elderly patients), signs of liver damage, severe skin reactions, or allergic reactions with face or throat swelling — require immediate medical attention. Stop taking this medication and seek emergency care right away if those occur.
Acetaminophen, Butalbital, and Caffeine warnings and precautions
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- Liver damage risk: Acetaminophen can cause acute liver failure, including cases requiring liver transplant or resulting in death. Risk is highest when the daily maximum is exceeded, when combined with alcohol, or when multiple acetaminophen-containing products are used together.
- Habit-forming potential: Butalbital is a barbiturate and can cause physical dependence. Extended or repeated use is not recommended for any of these products.
- Serious skin reactions: Rarely, acetaminophen has caused life-threatening skin reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). Stop the medication at the first sign of a rash and seek care.
- Serious allergic reactions: Anaphylaxis (a life-threatening allergic reaction) has been reported with acetaminophen. Symptoms include swelling of the face, mouth, or throat, difficulty breathing, hives, rash, and vomiting. Seek emergency care immediately.
- Mental/behavioral effects: Confusion, excitement, or depression can occur — particularly in elderly or debilitated patients or at high doses.
Acetaminophen, Butalbital, and Caffeine interactions
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This combination can interact with several medications and substances — always share a full medication list with your pharmacist:
- MAO inhibitors (a type of antidepressant): can amplify the sedative effects of butalbital — this combination should be avoided
- Alcohol: increases the risk of serious liver damage from acetaminophen and intensifies sedation from butalbital
- Other CNS depressants (sleeping pills, tranquilizers like chlordiazepoxide, opioid pain relievers): combining these with butalbital can dangerously increase sedation and suppress breathing
- General anesthetics: butalbital may enhance anesthetic effects — tell your surgical team you take this medication
- Other acetaminophen-containing products: using more than one product with acetaminophen (look for APAP on labels) raises the daily total and the risk of liver damage
Interactions listed in the FDA-approved label
From the Acetaminophen, 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.
- Other narcotic analgesics: Butalbital, acetaminophen, and caffeine may enhance the effects of other narcotic analgesics, causing increased CNS depression.
- Alcohol: Butalbital, acetaminophen, and caffeine may enhance the effects of alcohol, causing increased CNS depression.
- General anesthetics: Butalbital, acetaminophen, and caffeine may enhance the effects of general anesthetics, causing increased CNS depression.
- Tranquilizers such as chlordiazepoxide: Butalbital, acetaminophen, and caffeine may enhance the effects of tranquilizers such as chlordiazepoxide, causing increased CNS depression.
- Sedative-hypnotics: Butalbital, acetaminophen, and caffeine may enhance the effects of sedative-hypnotics, causing increased CNS depression.
- Other CNS depressants: Butalbital, acetaminophen, and caffeine may enhance the effects of other CNS depressants, causing increased CNS depression.
Read the label’s full interactions text
Drug Interactions 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.
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 Acetaminophen, Butalbital, and Caffeine
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- Tell your doctor if you have liver disease — the risk of acetaminophen-related liver damage is significantly higher
- Tell your doctor if you have porphyria (a rare metabolic condition) — this medication is contraindicated in that condition
- Tell your doctor if you have a known allergy to acetaminophen or any other ingredient in this product
- Tell your doctor if you drink alcohol regularly — this raises your risk of liver injury
- Older or debilitated patients may be more sensitive to butalbital's sedating effects and may experience confusion, excitement, or depression
- Pregnancy and breastfeeding: butalbital crosses the placenta and can appear in breast milk — discuss risks with your doctor before taking this medication
- Tell your doctor if you have a history of substance use or dependence — butalbital is a habit-forming barbiturate
Acetaminophen, Butalbital, and Caffeine overdose
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Taking too much of this combination is a medical emergency. An overdose can cause serious toxicity from the butalbital (drowsiness, confusion, coma, slowed breathing, low blood pressure) or from the acetaminophen (severe liver damage that may not appear for 48–72 hours after ingestion, along with early symptoms like nausea, vomiting, and sweating). Call Poison Control (1-800-222-1222) or go to an emergency room immediately — do not wait for symptoms to get worse. Early treatment, including activated charcoal and a medication called N-acetylcysteine (NAC) to protect the liver, can be life-saving when given quickly.
How your body processes Acetaminophen, Butalbital, and Caffeine
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All three ingredients are absorbed quickly from the gastrointestinal tract after oral dosing. Butalbital stays in the body the longest — it has a half-life (the time it takes the body to clear half of the drug) of about 35 hours and is eliminated mainly by the kidneys. Acetaminophen is processed rapidly, with a half-life of roughly 1.25 to 3 hours; it is broken down by the liver and the breakdown products leave in the urine. Caffeine also acts quickly, with a half-life of about 3 hours, and is mostly metabolized by the liver before being cleared in the urine. Both butalbital and caffeine can pass into breast milk and cross the placenta.
How to store Acetaminophen, Butalbital, and Caffeine
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Store and Dispense Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) ; dispense in a tight, light-resistant container as defined in the USP.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Acetaminophen, Butalbital, and Caffeine
306 supplements and herbal products have documented interactions with Acetaminophen, 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 · 15
- Moderate · 246
- Minor · 45
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
Acetaminophen, Butalbital, and Caffeine has been associated with lower levels of 2 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.
- Moderate · 1
- Unrated · 1
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Acetaminophen, Butalbital, and Caffeine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Acetaminophen, Butalbital, and Caffeine — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is this medication for? My doctor prescribed it for headaches — is that normal?
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Can I take this regularly if I get headaches a lot?
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I also take Tylenol sometimes. Is that a problem?
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Can I have a glass of wine while I'm taking this?
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What side effects should I expect, and which ones mean I should call for help?
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Is it safe to take this if I'm pregnant or breastfeeding?
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Is Acetaminophen, Butalbital, and Caffeine available over the counter?
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When was Acetaminophen, Butalbital, and Caffeine first available?
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Who makes Acetaminophen, Butalbital, and Caffeine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Acetaminophen, Butalbital, and Caffeine on HelloPharmacist
Acetaminophen, Butalbital, and Caffeine forms and strengths (how it comes)
Acetaminophen, Butalbital, and Caffeine is available in 3 forms. 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.
Tablet
How this form is used
- Butalbital, Acetaminophen and Caffeine tablets are used to relieve the symptoms of tension (muscle contraction) headache
- Butalbital, Acetaminophen and Caffeine tablets: take 1 or 2 tablets every 4 hours as needed; do not exceed 6 tablets per day
- Extended or repeated use is not recommended due to the risk of physical dependence
- Take by mouth; follow your prescriber's instructions and product label
Capsule
How this form is used
- Fioricet capsules are used to relieve the symptoms of tension (muscle contraction) headache
- Butalbital, Acetaminophen and Caffeine capsules are used to relieve the symptoms of tension headache
- Fioricet: take 1 or 2 capsules every 4 hours as needed; do not exceed 6 capsules in one day
- Butalbital, Acetaminophen and Caffeine capsules: take 1 or 2 capsules every 4 hours as needed; do not exceed 6 capsules per day
- Extended or repeated use of any capsule form is not recommended due to the risk of physical dependence
- Take by mouth; follow your prescriber's instructions and product label
Oral solution
How this form is used
- Butalbital, Acetaminophen and Caffeine oral solution is used to relieve the symptoms of tension (muscle contraction) headache
- Butalbital, Acetaminophen and Caffeine oral solution: take 1 or 2 tablespoonfuls (15 mL or 30 mL) every 4 hours as needed
- Do not exceed 6 tablespoonfuls of oral solution per day
- Extended or repeated use is not recommended due to the risk of physical dependence
- Take by mouth; follow your prescriber's instructions and product label
Acetaminophen, Butalbital, and Caffeine on the U.S. market: products, makers and brands
How Acetaminophen, 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.
34 companies list 65 Acetaminophen, Butalbital, and Caffeine product records with the FDA, mostly as tablet, capsule, oral solution; the earliest marketing or approval year on record is 1987. Brand names on the directory include Fioricet, Isocet, Zebutal and 13 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Acetaminophen, Butalbital, and Caffeine is used (Medicaid data)
A general measure of how commonly Acetaminophen, 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 Acetaminophen, 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 Acetaminophen, Butalbital, and Caffeine prescribed? Of the 1,601 medications we measure, Acetaminophen, Butalbital, and Caffeine ranks #282 by Medicaid prescriptions — more than 82% of them.
Utilization by Acetaminophen, 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.
acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet Most dispensed
Summed across the 19 of 247 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 238154
acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule
Summed across the 9 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 889520
acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule
Summed across the 5 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 238153
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 Acetaminophen, 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 33 of 288 listed Acetaminophen, Butalbital, and Caffeine NDCs with Medicaid activity.
Compare Acetaminophen, Butalbital, and Caffeine products
A representative set of FDA-listed product records for Acetaminophen, 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; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg | Oral | Actavis Pharma, Inc. × 2 listings | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg | Oral | Advanced Rx of Tennessee, LLC | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg | Oral | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Amici Pharma, Inc. | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Aurolife Pharma, LLC | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg | Oral | AvKARE | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1; BUTALBITAL 50 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Dr. Reddy's Labratories Inc. | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg | Oral | Quagen Pharmaceuticals Llc | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Quagen Pharmaceuticals Llc | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg | Oral | Seton Pharmaceuticals LLC | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Seton Pharmaceuticals LLC | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg | Oral | Solco Healthcare Us, Llc | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1; BUTALBITAL 50 mg | Oral | Sunrise Pharmaceutical, Inc | ANDA | View NDC → |
| 💊Oral solution | ||||
| BUTALBITAL 50 mg/15 mL; ACETAMINOPHEN 325 mg/15 mL; CAFFEINE 40 mg/15 mL | Oral | Genus Lifesciences Inc. | ANDA | View NDC → |
| 💊Tablet | ||||
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Advanced Rx of Tennessee, LLC × 2 listings | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Asclemed USA, Inc. | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | AvPAK | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Bryant Ranch Prepack × 9 listings | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Granules Pharmaceuticals Inc. | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Hawaii Repack, Inc. | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | KVK-Tech, Inc. | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Lgm Pharma Solutions, Llc | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Mikart, LLC | ANDA | View NDC → |
| ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Preferred Pharmaceuticals Inc. × 3 listings | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Proficient Rx LP × 4 listings | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Quagen Pharmaceuticals Llc | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Redpharm Drug | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| ACETAMINOPHEN 325 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | St. Mary's Medical Park Pharmacy | ANDA | View NDC → |
| BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | Oral | Westminster Pharmaceuticals, LLC | ANDA | View NDC → |
Showing 65 of 65 products — FDA National Drug Code Directory. See every product, package size and price: browse all 65 Acetaminophen, Butalbital, and Caffeine NDCs →
Acetaminophen, 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 Acetaminophen, 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 Acetaminophen, 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.
Acetaminophen, Butalbital, and Caffeine FDA approval history
How Acetaminophen, Butalbital, and Caffeine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Acetaminophen, 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 Acetaminophen, Butalbital, and Caffeine recalls since July 2021.
✅No Acetaminophen, Butalbital, and Caffeine recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 214130 3 dose forms · 6 strengths
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Dose form (SCDF) Oral Capsule RxCUI 374750In current FDA listingsClinical drug / strength (SCD) acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MGRxCUI 889520acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MGRxCUI 238153acetaminophen 500 MG / butalbital 50 MG / caffeine 40 MGRxCUI 308322 -
Dose form (SCDF) Oral Solution RxCUI 452725In current FDA listingsClinical drug / strength (SCD) acetaminophen 21.7 MG/ML / butalbital 3.33 MG/ML / caffeine 2.67 MG/MLRxCUI 756245 -
Dose form (SCDF) Oral Tablet RxCUI 374751In current FDA listingsClinical drug / strength (SCD) acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MGRxCUI 238154acetaminophen 500 MG / butalbital 50 MG / caffeine 40 MGRxCUI 240093
Look up RxCUI 214130 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Acetaminophen, Butalbital, and Caffeine supply and shortage status
Whether Acetaminophen, 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 Acetaminophen, 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 | |
|---|---|---|---|
| Tablet · Oral | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | $0.122 per tablet | NDC details & price history |
| Tablet · Oral | 325; 50; 40 mg/1; mg/1; mg | $0.122 per tablet | NDC details & price history |
| Capsule · Oral | 300; 50; 40 mg/1; mg/1; mg | $0.316 per capsule | NDC details & price history |
| Capsule · Oral | BUTALBITAL 50 mg/1; ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg | $0.316 per capsule | NDC details & price history |
| Capsule · Oral | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | $1.93 per capsule | NDC details & price history |
| Capsule · Oral | 325; 50; 40 mg/1; mg/1; mg | $1.93 per capsule | NDC details & price history |
| Capsule · Oral | ACETAMINOPHEN 300 mg/1; CAFFEINE 40 mg/1; BUTALBITAL 50 mg | $0.316–$0.586 per capsule | NDC details & price history |
| Capsule · Oral | ACETAMINOPHEN 300 mg/1; BUTALBITAL 50 mg/1; CAFFEINE 40 mg | $0.316 per capsule | NDC details & price history |
| Tablet, Coated · Oral | 325; 50; 40 mg/1; mg/1; mg | $0.122 per tablet | NDC details & price history |
| Tablet | BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg | $0.122 per tablet | 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.
Acetaminophen, Butalbital, and Caffeine brand names
Acetaminophen, Butalbital, and Caffeine is sold under 16 brand names in the FDA directory — Fioricet, Isocet, Zebutal, Two-Dyne and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Acetaminophen, Butalbital, and Caffeine: manufacturers and labelers
34 companies list Acetaminophen, Butalbital, and Caffeine products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Proficient Rx LP, Actavis Pharma, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 10 more on the FDA NDC directory.
Acetaminophen, Butalbital, and Caffeine drug class (RxNorm)
Acetaminophen, Butalbital, and Caffeine belongs to the Anilides 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 Acetaminophen, 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. Taro Pharmaceuticals U.S.A., Inc. 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 →