Medicine guide

Butalbital, Acetaminophen and Caffeine

50 mg + 325 mg + 40 mg · Tablet

Prescription only
Controlled substance · CIII
Barbiturate

Active substance: Butalbital, Acetaminophen and Caffeine
Used in: Breathing, airways, allergies and cough
Made by: ST. MARY'S MEDICAL PARK PHARMACY
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-05-23

What it is

Barbiturate

Used for

Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

The label’s usual adult dose

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.

Full directions ↓

Serious warning

Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.

All warnings ↓

Good to know

Prescription only
Controlled substance (schedule III) — extra rules apply to prescribing and refills
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

27other products contain Butalbital, Acetaminophen and Caffeine — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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 butalbital, acetaminophen, and caffeine tablets in the treatment of multiple recurrent headaches is unavailable.
Caution in this regard is required because butalbital is habit-forming and potentially abusable.

From the official label · 2025-05-23 · DailyMed

How it works

From this product’s own US prescribing label.

Butalbital, acetaminophen, and caffeine tablets is intended as a treatment for tension headache.
It consists of a fixed combination of butalbital, acetaminophen and caffeine.

Half-life35 h

Mostly cleared after≈ 7 daysfive half-lives — our arithmetic

How it leaves the body

Of the material excreted in the urine, 32% is conjugated.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-05-23

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the 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.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

This product is contraindicated under the following conditions:
–Hypersensitivity or intolerance to any component of this product –Patients with porphyria.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Consequently, the extended use of butalbital, acetaminophen, and caffeine tablets is not recommended.
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 skin 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 immediately and seek medical care if they experience these symptoms.
Do not prescribe Butalbital, Acetaminophen and Caffeine Tablets for patients with acetaminophen allergy.
GENERAL Butalbital, acetaminophen and caffeine tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions. INFORMATION FOR PATIENTS/CAREGIVERS
For information on use in geriatric patients, see PRECAUTIONS/Geriatric Use . LABORATORY TESTS In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests. 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 Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility. PREGNANCY Teratogenic Effects Animal reproduction studies have not been conducted with butalbital, acetaminophen, and caffeine tablets. 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. NURSING MOTHERS 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. PEDIATRIC USE Safety and effectiveness in pediatric patients below the age of 12 have not been established. GERIATRIC USE Clinical studies of butalbital, acetaminophen and caffeine tablets 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.
GENERAL Butalbital, acetaminophen and caffeine tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Teratogenic Effects Animal reproduction studies have not been conducted with butalbital, acetaminophen, and caffeine tablets.
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.
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.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

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.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

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.
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 butalbital, acetaminophen, and caffeine tablets 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.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Abuse and Dependence Butalbital Barbiturates may be habit-forming:
Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates.
The average daily dose for the barbiturate addict is usually about 1500 mg.
As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold.
As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller.
The lethal dose of a barbiturate is far less if alcohol is also ingested.
Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs.
Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days.
Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug.
Barbituratedependent patients can be withdrawn by using a number of different withdrawal regimens.
One method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical studies of butalbital, acetaminophen and caffeine tablets 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

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.
To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc., at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

/CAREGIVERS
Do not take Butalbital, Acetaminophen and Caffeine Tablets
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 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.
Butalbital, acetaminophen and caffeine tablets 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 butalbital, acetaminophen, and caffeine tablets, 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 .

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

Butalbital, Acetaminophen and Caffeine Tablets USP, 50 mg/325 mg/40 mg Each Butalbital, Acetaminophen, and Caffeine Tablet contains butalbital 50 mg, acetaminophen 325 mg and caffeine 40 mg.
Tablets are White to off-white, round shaped tablets debossed with ‘G 149’ on one side and plain on other side.
NDC 60760-865-12 BOTTLES OF 12 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) [see USP Controlled Room Temperature]; dispense in a tight, light-resistant container as defined in the USP.
Revised: 04/2022 LB0034-02

Quoted from the official label, section “How Supplied”.

What is in it

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, sodium starch glycolate and magnesium stearate.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate.
It has the following structural formula: C 11 H 16 N 2 O 3 M.W. =
224.26 Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic.
It has the following structural formula.
C 8 H 9 NO 2 M.W. =
151.16 Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant.
It has the following structural formula: C 8 H 10 N 4 O 2 M.W. =
Fig-1 Fig-2 Fig-3

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (13)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 13 of 13

Details

Made by	ST. MARY'S MEDICAL PARK PHARMACY
Active substance	Butalbital, Acetaminophen and Caffeine
Used in	Breathing, airways, allergies and cough
Strength	50 mg + 325 mg + 40 mg
Form	Tablet
Route	Oral
Packs	12 TABLET in 1 BOTTLE, PLASTIC
NDC	60760-865

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

31 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Capsule16 products
- 50 mg + 325 mg + 40 mg8
  50 mg + 325 mg + 40 mg · 8 companies
- 50 mg + 300 mg + 40 mg6
  50 mg + 300 mg + 40 mg · 6 companies
- 300 mg + 40 mg + 50 mg2
  300 mg + 40 mg + 50 mg · 2 companies
  - Bryant Ranch Prepack
  - SUNRISE PHARMACEUTICAL, INC
Tablet14 products
- 50 mg + 325 mg + 40 mg14
  50 mg + 325 mg + 40 mg · 14 companies
  +6 more
Solution1 products
- 50 mg/15mL + 325 mg/15mL + 40 mg/15mL

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Butalbital, Acetaminophen and Caffeine