Butalbital, Acetaminophen, and Caffeine 50 mg; 325 mg; 40 mg Tablet, 84-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Anilides class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Acetaminophen, butalbital, and caffeine is used to relieve tension headaches. Acetaminophen is in a class of medications called analgesics (pain relievers). It works by changing the way the body senses pain. Butalbital is in a class of medications called barbiturates. It works by having a relaxing effect on the brain and central nervous system (CNS). Caffeine is a CNS stimulant. It works by changing the amounts of certain natural substances in the brain.
Read the full MedlinePlus article ↗- Yes, that's exactly what it's intended for. This combination of butalbital, acetaminophen, and caffeine is prescribed specifically to relieve tension headaches — the kind caused by...
- What exactly is this medication for? My doctor prescribed it for headaches — is that normal?
- This is actually something to be careful about. Butalbital, one of the ingredients, is habit-forming — meaning your body can become physically dependent on it if you take it freque...
- Can I take this regularly if I get headaches a lot?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2851 | $23.95 / 84 tablets |
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🔁 Therapeutic equivalents
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63629-8392-00 You're viewing this | 84 TABLET in 1 BOTTLE (63629-8392-0) | 2020-12-17 | Active |
| 63629-8392-01 | 20 TABLET in 1 BOTTLE (63629-8392-1) | 2020-12-17 | Active |
| 63629-8392-02 | 30 TABLET in 1 BOTTLE (63629-8392-2) | 2020-12-17 | Active |
| 63629-8392-03 | 60 TABLET in 1 BOTTLE (63629-8392-3) | 2020-12-17 | Active |
| 63629-8392-04 | 90 TABLET in 1 BOTTLE (63629-8392-4) | 2020-12-17 | Active |
| 63629-8392-05 | 50 TABLET in 1 BOTTLE (63629-8392-5) | 2020-12-17 | Active |
| 63629-8392-06 | 6 TABLET in 1 BOTTLE (63629-8392-6) | 2020-12-17 | Active |
| 63629-8392-07 | 120 TABLET in 1 BOTTLE (63629-8392-7) | 2020-12-17 | Active |
| 63629-8392-08 | 40 TABLET in 1 BOTTLE (63629-8392-8) | 2020-12-17 | Active |
| 63629-8392-09 | 12 TABLET in 1 BOTTLE (63629-8392-9) | 2020-12-17 | Active |
You're viewing one of 10 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 63629-8392-00?
What is the difference between NDC 63629-8392-00 and NDC 63629-8392-06?
What NDC number is used to bill for this package of Butalbital, Acetaminophen, and Caffeine 50 mg; 325 mg; 40 mg Tablet?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Butalbital, acetaminophen, and caffeine tablets, USP 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION One or 2 tablets every 4 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.
⛔ Contraindications ▾
CONTRAINDICATIONS This product is contraindicated under the following conditions: - Hypersensitivity or intolerance to any component of this product - Patients with porphyria.
⚠️ Warnings ▾
WARNINGS 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. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
Serious Skin Reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Hypersensitivity/anaphylaxis There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen.
Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue butalbital, acetaminophen, and caffeine tablets, USP immediately and seek medical care if they experience these symptoms.
Do not prescribe butalbital, acetaminophen, and caffeine tablets, USP for patients with acetaminophen allergy. Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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.
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.
🔄 Drug Interactions ▾
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.
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
🤰 Pregnancy ▾
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.
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.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 have not been established.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of butalbital, acetaminophen, and caffeine tablets, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Butalbital is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🆘 Overdosage ▾
OVERDOSAGE 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 include drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.
In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, 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. In adults hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams. Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.
Treatment A single or multiple 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY This combination drug product is intended as a treatment for tension headache. It consists of a fixed combination of butalbital, acetaminophen, and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.
Pharmacokinetics The behavior of the individual components is described below. Butalbital Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier.
They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility. Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours.
Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2, 3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5(3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated. The in vitro plasma protein binding of butalbital is 45% over the concentration range of 0.5-20 mcg/mL.
This falls within the range of plasma protein binding (20%-45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity, indicating that there is no preferential distribution of butalbital into either plasma or blood cells. See OVERDOSAGE for toxicity information.
Acetaminophen Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites.
Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See OVERDOSAGE for toxicity information. Caffeine Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.
Caffeine is cleared through metabolism and excretion in the urine. The plasma half-life is about 3 hours. Hepatic biotransformation prior to excretion results in about equal amounts of 1-methylxanthine and 1-methyluric acid.
Of the 70% of the dose that is recovered in the urine, only 3% is unchanged drug. See OVERDOSAGE for toxicity information.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Butalbital, Acetaminophen, and Caffeine Tablets, USP contain 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325mg/40 mg are light-blue, speckled, round uncoated tablets, debossed "1695" on one side and "LCI" on the other side and are supplied in: NDC: 63629-8392-1: 20 Tablets in a BOTTLE NDC: 63629-8392-2: 30 Tablets in a BOTTLE NDC: 63629-8392-3: 60 Tablets in a BOTTLE NDC: 63629-8392-4: 90 Tablets in a BOTTLE NDC: 63629-8392-5: 50 Tablets in a BOTTLE NDC: 63629-8392-6: 6 Tablets in a BOTTLE NDC: 63629-8392-7: 120 Tablets in a BOTTLE NDC: 63629-8392-8: 40 Tablets in a BOTTLE NDC: 63629-8392-9: 12 Tablets in a BOTTLE NDC: 63629-8392-0: 84 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
📋 Description ▾
DESCRIPTION Butalbital, Acetaminophen, and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients: Butalbital, USP . . . . . . . . . .50 mg Acetaminophen, USP . . . . .325 mg Caffeine, USP . . . . . . . . . . .40 mg Inactive Ingredients: microcrystalline cellulose, crospovidone, croscarmellose sodium, corn starch, stearic acid, colloidal silicon dioxide, magnesium stearate, and FD&C Blue No. 1.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula: Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant.
It has the following structural formula:
💬 Information for Patients ▾
Information for Patients/Caregivers This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product. Alcohol and other CNS depressants may produce an additive CNS depression when taken with this combination product, and should be avoided.
Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed. For information on use in geriatric patients, see PRECAUTIONS/Geriatric Use .
Do not take butalbital, acetaminophen, and caffeine tablets, USP if you are allergic to any of its ingredients. If you develop signs of allergy such as a rash or difficulty breathing stop taking butalbital, acetaminophen, and caffeine tablets, USP and contact your healthcare provider immediately. Do not take more than 4000 milligrams of acetaminophen per day.
Call your doctor if you took more than the recommended dose.