Quick answers
- What is Butalbital, acetaminophen and caffeine used for?
- The FDA-approved label (Butalbital, Acetaminophen, Caffeine, Remedyrepack Inc., September 3, 2026) says: “Butalbital, acetaminophen and caffeine tablets 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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Butalbital, acetaminophen and caffeine?
- The “Adverse Reactions” section of the FDA label (Butalbital, Acetaminophen, Caffeine, Remedyrepack Inc., September 3, 2026) begins: “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.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Butalbital, acetaminophen and caffeine?
- The “Drug Interactions” section of the FDA label (Butalbital, Acetaminophen, Caffeine, Remedyrepack Inc., September 3, 2026) begins: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Butalbital, acetaminophen and caffeine have a boxed warning?
- Yes. The FDA label for Butalbital, Acetaminophen, Caffeine has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Butalbital, acetaminophen and caffeine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Butalbital, acetaminophen and caffeine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Butalbital, acetaminophen and caffeine?
- 35 companies list prescription products of Butalbital, acetaminophen and caffeine in the FDA NDC Directory, including Bryant Ranch Prepack, Proficient Rx LP and Actavis Pharma, Inc.
What Butalbital, acetaminophen and caffeine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Butalbital, acetaminophen and caffeine tablets 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 label: Butalbital, Acetaminophen, Caffeine, Remedyrepack Inc., effective September 3, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, oral), Butalbital, Acetaminophen, Caffeine, Remedyrepack Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 63 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
62 of 63 FDA labels for this medicine have a boxed warning.
Butalbital, acetaminophen and caffeine boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
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.
— FDA label: Butalbital, Acetaminophen, Caffeine, Remedyrepack Inc., effective September 3, 2026. Read the full label on DailyMed →
Butalbital, acetaminophen and caffeine side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
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.
Read more of this section
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. Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions. Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported. The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in the OVERDOSAGE section. Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis. Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia. To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
— FDA label: Butalbital, Acetaminophen, Caffeine, Remedyrepack Inc., effective September 3, 2026. Read the full label on DailyMed →
Butalbital, acetaminophen and caffeine drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
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.
— FDA label: Butalbital, Acetaminophen, Caffeine, Remedyrepack Inc., effective September 3, 2026. Read the full label on DailyMed →
Butalbital, acetaminophen and caffeine dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
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.
— FDA label: Butalbital, Acetaminophen, Caffeine, Remedyrepack Inc., effective September 3, 2026. Read the full label on DailyMed →
Butalbital, acetaminophen and caffeine in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital, acetaminophen and caffeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.
Read more of this section
Nonteratogenic Effects Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last two months of pregnancy. Butalbital was found in the infant's serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.
— FDA label: Butalbital, Acetaminophen, Caffeine, Remedyrepack Inc., effective September 3, 2026. Read the full label on DailyMed →
Butalbital, acetaminophen and caffeine and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
Caffeine, barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital, acetaminophen and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
— FDA label: Butalbital, Acetaminophen, Caffeine, Remedyrepack Inc., effective September 3, 2026. Read the full label on DailyMed →
When Butalbital, acetaminophen and caffeine should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product Patients with porphyria.
— FDA label: Butalbital, Acetaminophen, Caffeine, Remedyrepack Inc., effective September 3, 2026. Read the full label on DailyMed →
Butalbital, acetaminophen and caffeine overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Following an acute overdosage of butalbital, acetaminophen and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation. Signs and Symptoms Toxicity from barbiturate poisoning includes drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.
Read more of this section
In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles. Treatment A single or multiple drug overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered. Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration. Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.
— FDA label: Butalbital, Acetaminophen, Caffeine, Remedyrepack Inc., effective September 3, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet · Capsule · Solution |
|---|---|
| Route | Oral |
| Prescription products | 67 in the FDA NDC Directory |
| Brand names | Fioricet |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| acetaminophen 300 mg · butalbital 50 mg · caffeine 40 mg capsule | Generic | $0.3526 per capsule |
| acetaminophen 300 mg · butalbital 50 mg · caffeine 40 mg capsule | Brand: Fioricet | $8.82 per capsule |
| acetaminophen 325 mg · butalbital 50 mg · caffeine 40 mg capsule | Generic | $1.65 per capsule |
| acetaminophen 325 mg · butalbital 50 mg · caffeine 40 mg tablet | Generic | $0.1208 per tablet |
NADAC list of November 4, 2026; these prices took effect between January 1, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack14 products
- Proficient Rx LP4 products
- Actavis Pharma, Inc.3 products
- Remedyrepack Inc.3 products
- Quagen Pharmaceuticals LLC3 products
- Lannett Company, Inc.3 products
- Preferred Pharmaceuticals Inc.3 products
- Advanced Rx of Tennessee, LLC3 products
- Direct_Rx2 products
- Seton Pharmaceuticals LLC2 products
- A-S Medication Solutions2 products
- Granules Pharmaceuticals Inc.2 products
- Hawaii Repack, Inc.1 product
- Aurolife Pharma, LLC1 product
- AvKARE1 product
- KVK-Tech, Inc.1 product
- Mikart, LLC1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Asclemed USA, Inc.1 product
- Cardinal Health 107, LLC1 product
- Genus Lifesciences Inc.1 product
- LGM Pharma Solutions, LLC1 product
- Chartwell RX, LLC1 product
- AvPAK1 product
- Westminster Pharmaceuticals, LLC1 product
- Major Pharmaceuticals1 product
- Advanced Rx Pharmacy of Tennessee, LLC1 product
- Solco Healthcare US, LLC1 product
- Golden State Medical Supply, Inc.1 product
- St. Mary's Medical Park Pharmacy1 product
- NuCare Pharmaceuticals, Inc.1 product
- Amici Pharma, Inc.1 product
- Dr. Reddy's Labratories Inc.1 product
- Sunrise Pharmaceutical, Inc.1 product
- Redpharm Drug1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (19)
- ANDA088616Actavis Labs Ut Inc · November 9, 1984
- ANDA089007DR Reddys Labs SA · March 17, 1986
- ANDA089175Pharmobedient · January 21, 1987
- ANDA040387Genus · January 31, 2003
- ANDA040864Granules · December 1, 2008
- ANDA040885Lgm Pharma · November 16, 2009
- ANDA200243Lannett Co Inc · September 13, 2012
- ANDA207118Nuvo Pharms Inc · October 28, 2016
- ANDA204733Aurolife Pharma LLC · September 26, 2018
- ANDA211106Abhai LLC · September 26, 2018
- ANDA209587Lgm Pharma · October 31, 2018
- ANDA212082Lannett Co Inc · December 17, 2019
- ANDA212083Lannett Co Inc · December 17, 2019
- ANDA213321Granules · April 8, 2020
- ANDA213046Taro · July 1, 2020
- ANDA214087Pharmazone · August 13, 2021
- ANDA214287Quagen · January 18, 2024
- ANDA214288Quagen · February 8, 2024
- ANDA216376Quagen · March 12, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 238153, 238154, 889520, 1432261 |
|---|---|
| SPL set ID of the quoted label | dc2bb7fc-1722-4865-a02c-be5e5c211505 |
| FDA labels (SPL) | 63 |
| FDA applications | 19 ANDA |
| Active ingredients (FDA) | ACETAMINOPHEN / BUTALBITAL / CAFFEINE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Butal/APAP/CaffBrand page: products, maker and price
- Butal/Apap/CaffeineBrand page: products, maker and price
- FioricetBrand page: products, maker and price
- Bryant Ranch PrepackMaker or distributor
- Proficient Rx LPMaker or distributor
- Actavis Pharma, Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Butalbital, Acetaminophen, Caffeine, Remedyrepack Inc., effective September 3, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →