Medicine guide

Butalbital and Acetaminophen

50 mg + 300 mg · Tablet

Prescription only
Controlled substance · CIII
Barbiturate

Active substance: Butalbital and Acetaminophen
Used in: Pain, sleep, mood, epilepsy and the brain
Made by: QUAGEN PHARMACEUTICALS LLC
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 · 2024-05-06

What it is

Barbiturate

Used for

Butalbital and Acetaminophen Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

The label’s usual adult dose

Butalbital and Acetaminophen Tablets 50 mg/300 mg:

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

14other products contain Butalbital and Acetaminophen — 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 and Acetaminophen 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.

From the official label · 2024-05-06 · DailyMed

How it works

From this product’s own US prescribing label.

This combination drug product is intended as a treatment for tension headache.
It consists of a fixed combination of butalbital and acetaminophen.

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 · 2024-05-06

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.

Butalbital and Acetaminophen Tablets 50 mg/300 mg:
One or two tablets every four hours. Total daily dosage should not exceed 6 tablets. Extended and repeated use of these products is not recommended because of the potential for physical dependence.

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

Other warnings

Consequently, the extended use of this product 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 and Acetaminophen Tablets immediately and seek medical care if they experience these symptoms.
Do not prescribe Butalbital and Acetaminophen Tablets for patients with acetaminophen allergy.
General Butalbital and Acetaminophen 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 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.
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.
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 this combination product.
Nursing mothers Barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known.
Pediatric use Safety and effectiveness in children below the age of 12 have not been established.
General Butalbital and Acetaminophen 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.
Drug/laboratory test interactions Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Teratogenic Effects Animal reproduction studies have not been conducted with this combination product.
It is also not known whether butalbital and acetaminophen can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
These products 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.
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 and acetaminophen, 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 and acetaminophen 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 and acetaminophen, toxicity may result from the barbiturate or the acetaminophen.
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 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.
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.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Abuse and Dependence:
Butalbital :
Barbiturates may be habit-forming:
T olerance, 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.
Barbiturate-dependent 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 children below the age of 12 have not been established.

Quoted from the official label, section “Pediatric 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:
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: 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.
To report SUSPECTED ADVERSE REACTIONS , contact Quagen Pharmaceuticals LLC at1-888-344-9603 or www.quagenpharma.com, 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

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 Central Nervous System (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.
Do not take Butalbital and Acetaminophen 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 and Acetaminophen 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.

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

What it looks like and how it is packed

Yellow, round, biconvex unscored tablets debossed " T abov e 2 8 " on one side and plain on the other side, in bottles of 100 (NDC 70752-147-10) and bottles of 500 (NDC 70752-147-14).
Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight container as defined in the USP.

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

What is in it

Each Butalbital and Acetaminophen Tablet for oral administration, contains Butalbital, USP 50 mg, Acetaminophen, USP 300 mg.
In addition, each Butalbital and Acetaminophen Tablet contains the following inactive ingredients:
Colloidal Silicon Dioxide, Crospovidone, Croscarmellose Sodium, Povidone, Microcrystalline Cellulose, Pregelatinized Starch, D&C Yellow #10 Lake, FD&C Red #40 Lake and Stearic Acid.
Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate.
It has the following structural formula: MOLECULAR WEIGHT =
224.26 Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic.
It has the following structural formula:
MOLECULAR WEIGHT = 151.16 chemsture-butalbital chemsture-acetaminophen

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.

Colour dyesD&C Yellow #10 Lake; FD&C Red #40 LakeSome people react to dyes such as tartrazine (Yellow 5) or carmine.

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 (2)

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

Showing 2 of 2

Details

Made by	QUAGEN PHARMACEUTICALS LLC
Active substance	Butalbital and Acetaminophen
Used in	Pain, sleep, mood, epilepsy and the brain
Strength	50 mg + 300 mg
Form	Tablet
Route	Oral
Packs	100 TABLET in 1 BOTTLE, PLASTIC · 500 TABLET in 1 BOTTLE, PLASTIC
NDC	70752-147

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).

Report wrong or outdated information on this page

Other strengths and forms

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

Tablet12 products
- 25 mg + 325 mg
- 50 mg + 300 mg3
  50 mg + 300 mg · 3 companies
  - Burel Pharmaceuticals, LLC
  - Oceanside Pharmaceuticals
  - QUAGEN PHARMACEUTICALS LLC · this page
- 50 mg + 325 mg4
  50 mg + 325 mg · 4 companies
- 300 mg + 50 mg2
  300 mg + 50 mg · 2 companies
  - Aarkish Pharmaceuticals NJ Inc.
  - Amici Pharma, Inc.
- 325 mg + 50 mg
- 325 mg + 25 mg
Capsule2 products
- 50 mg + 300 mg2
  50 mg + 300 mg · 2 companies
  - Dr. Reddy's Labratories Inc.
  - Granules Pharmaceuticals Inc.

Same active substance

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

See every product with Butalbital and Acetaminophen