Medicine guide

Butalbital, Aspirin, and Caffeine

50 mg + 325 mg + 40 mg · Capsule

Prescription only
Controlled substance · CIII
Barbiturate

Active substance: Butalbital, Aspirin, and Caffeine
Used in: Breathing, airways, allergies and cough
Made by: Sandoz Inc
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 · 2024-12-02

What it is

Barbiturate

Used for

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

The label’s usual adult dose

One or 2 capsules every 4 hours. Total daily dose should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.

Full directions ↓

Do not take it if

Butalbital, aspirin, and caffeine capsules are contraindicated under the following conditions:

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

4other products contain Butalbital, Aspirin, 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, aspirin, and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of butalbital, aspirin, and caffeine capsules 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 · 2024-12-02 · DailyMed

How it works

From this product’s own US prescribing label.

Pharmacologically, butalbital, aspirin, and caffeine capsules combine the analgesic properties of aspirin with the anxiolytic and muscle relaxant properties of butalbital.
The clinical effectiveness of butalbital, aspirin, and caffeine capsules in tension headache has been established in double-blind, placebo-controlled, multi-clinic trials.

Peak level after40 min

Half-life12 min

Mostly cleared after≈ 1 hfive half-lives — our arithmetic

How it leaves the body

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

With food

Aspirin The systemic availability of aspirin after an oral dose is highly dependent on the dosage form, the presence of food, the gastric emptying time, gastric pH, antacids, buffering agents, and particle size.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-12-02

Do not take it if

Butalbital, aspirin, and caffeine capsules are contraindicated under the following conditions:
Hypersensitivity or intolerance to aspirin, caffeine, or butalbital.
Patients with a hemorrhagic diathesis (e.g., hemophilia, hypoprothrombinemia, von Willebrand's disease, the thrombocytopenias, thrombasthenia and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency and severe liver damage).
Patients with the syndrome of nasal polyps, angioedema and bronchospastic reactivity to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylactoid reactions have occurred in such patients.
Peptic ulcer or other serious gastrointestinal lesions.
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.

One or 2 capsules every 4 hours. Total daily dose should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.

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

Other warnings

Therapeutic doses of aspirin can cause anaphylactic shock and other severe allergic reactions.
It should be ascertained if the patient is allergic to aspirin, although a specific history of allergy may be lacking.
Significant bleeding can result from aspirin therapy in patients with peptic ulcer or other gastrointestinal lesions, and in patients with bleeding disorders.
Aspirin administered preoperatively may prolong the bleeding time.
Consequently, the extended use of butalbital, aspirin, and caffeine capsules is not recommended.
Results from epidemiologic studies indicate an association between aspirin and Reye's Syndrome.
Caution should be used in administering this product to children, including teenagers, with chicken pox or flu.
Fetal Toxicity Premature Closure of Fetal Ductus Arteriosus
Avoid use of NSAIDs, including butalbital, aspirin, and caffeine capsules, in pregnant women at about 30 weeks gestation and later.
NSAIDs including butalbital, aspirin, and caffeine capsules, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.
Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs, including butalbital, aspirin, and caffeine capsules, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
Oligohydramnios is often, but not always, reversible with treatment discontinuation.
Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation.
In some post-marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit butalbital, aspirin, and caffeine capsules use to the lowest effective dose and shortest duration possible.
Consider ultrasound monitoring of amniotic fluid if butalbital, aspirin, and caffeine capsules treatment extends beyond 48 hours.
Discontinue butalbital, aspirin, and caffeine capsules if oligohydramnios occurs and follow up according to clinical practice [ see PRECAUTIONS;
Pregnancy ].
Serious Skin Reactions NSAIDs, including aspirin, a component of butalbital, aspirin, and caffeine capsules, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
NSAIDs can also cause fixed drug eruption (FDE).
FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.
These serious events may occur without warning.
Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of butalbital, aspirin, and caffeine capsules at the first appearance of skin rash or any other sign of hypersensitivity.
Butalbital, aspirin, and caffeine capsules are contraindicated in patients with previous serious skin reactions to NSAIDs [ see CONTRAINDICATIONS ].
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as butalbital, aspirin, and caffeine capsules.
Some of these events have been fatal or life-threatening.
DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling.
Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis.
Sometimes symptoms of DRESS may resemble an acute viral infection.
Eosinophilia is often present.
Because this disorder is variable in its presentation, other organ systems not noted here may be involved.
It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
If such signs or symptoms are present, discontinue butalbital, aspirin, and caffeine capsules and evaluate the patient immediately.
General Butalbital, aspirin, and caffeine capsules should be prescribed with caution for certain special-risk patients such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, coagulation disorders, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison's disease, or prostatic hypertrophy. Aspirin should be used with caution in patients on anticoagulant therapy and in patients with underlying hemostatic defects, and extreme caution in the presence of peptic ulcer. Precautions should be taken when administering salicylates to persons with known allergies. Hypersensitivity to aspirin is particularly likely in patients with nasal polyps, and relatively common in those with asthma. Information for Patients Patients should be informed that butalbital, aspirin, and caffeine capsules contain aspirin and should not be taken by patients with an aspirin allergy. Serious Skin Reactions, including DRESS Advise patients to stop taking butalbital, aspirin, and caffeine capsules immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [ see WARNINGS ]. Butalbital, aspirin, and caffeine capsules may impair the mental and/or physical abilities required for performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking butalbital, aspirin, and caffeine capsules. Alcohol and other CNS depressants may produce an additive CNS depression when taken with butalbital, aspirin, and caffeine capsules 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. Pregnancy Embryo-Fetal Toxicity Inform pregnant women to
avoid use of aspirin and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with butalbital, aspirin, and caffeine capsules is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [ see WARNINGS; Fetal Toxicity , PRECAUTIONS; Pregnancy ]. 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. In patients receiving concomitant corticosteroids and chronic use of aspirin, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance. Butalbital, aspirin, and caffeine capsules may enhance the effects of:
Uricosuric agents such as probenecid and sulfinpyrazone, reducing their effectiveness in the treatment of gout. Aspirin competes with these agents for protein binding sites. Drug/Laboratory Test Interactions Aspirin Aspirin may interfere with the following laboratory determinations in blood:
serum amylase, fasting blood glucose, cholesterol, protein, serum glutamic-oxaloacetic transaminase (SGOT), uric acid, prothrombin time and bleeding time. Aspirin may interfere with the following laboratory determinations in urine:
glucose, 5-hydroxyindoleacetic acid, Gerhardt ketone, vanillylmandelic acid (VMA), uric acid, diacetic acid, and spectrophotometric detection of barbiturates. Carcinogenesis, Mutagenesis, Impairment of Fertility Adequate long-term studies have been conducted in mice and rats with aspirin, alone or in combination with other drugs, in which no evidence of carcinogenesis was seen. No adequate studies have been conducted in animals to determine whether aspirin has a potential for mutagenesis or impairment of fertility. No adequate studies have been conducted in animals to determine whether butalbital has a potential for carcinogenesis, mutagenesis, or impairment of fertility. Pregnancy Risk Summary Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last 2 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. Use of NSAIDs, including butalbital, aspirin, and caffeine capsules, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of butalbital, aspirin, and caffeine capsules use between about 20 and 30 weeks of gestation, and
avoid butalbital, aspirin, and caffeine capsules use at about 30 weeks of gestation and later in pregnancy [ see WARNINGS; Fetal Toxicity ]. Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including butalbital, aspirin, and caffeine capsules, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Animal reproduction studies have not been conducted with butalbital, aspirin, and caffeine capsules. It is also not known whether butalbital, aspirin, and caffeine capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Butalbital, aspirin, and caffeine capsules should be given to a pregnant woman only when clearly needed. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as aspirin, resulted in increased pre- and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus
Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including butalbital, aspirin, and caffeine capsules, can cause premature closure of the fetal ductus arteriosus [ see WARNINGS; Fetal Toxicity ]. Oligohydramnios/Neonatal Renal Impairment If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If butalbital, aspirin, and caffeine capsules treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue butalbital, aspirin, and caffeine capsules and follow up according to clinical practice [ see WARNINGS; Fetal Toxicity ]. Data Human Data Premature Closure of Fetal Ductus Arteriosus Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Published studies and post-marketing reports describe maternal NSAID use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. In many cases, but not all, the decrease in amniotic fluid was transient and reversible with cessation of the drug. There have been a limited number of case reports of maternal NSAID use and neonatal renal dysfunction without oligohydramnios, some of which were irreversible. Some cases of neonatal renal dysfunction required treatment with invasive procedures, such as exchange transfusion or dialysis. Methodological limitations of these post-marketing studies and reports include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and concomitant use of other medications. These limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAID use. Because the published safety data on neonatal outcomes involved mostly preterm infants, the generalizability of certain reported risks to the full-term infant exposed to NSAIDs through maternal use is uncertain. Labor and Delivery Ingestion of aspirin prior to delivery may prolong delivery or lead to bleeding in the mother or neonate. Nursing Mothers Aspirin, caffeine, and barbiturates 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, aspirin, and caffeine capsules, 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 have not been established.
General Butalbital, aspirin, and caffeine capsules should be prescribed with caution for certain special-risk patients such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, coagulation disorders, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison's disease, or prostatic hypertrophy.
Aspirin should be used with caution in patients on anticoagulant therapy and in patients with underlying hemostatic defects, and extreme caution in the presence of peptic ulcer.
Precautions should be taken when administering salicylates to persons with known allergies.
Hypersensitivity to aspirin is particularly likely in patients with nasal polyps, and relatively common in those with asthma.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Aspirin, caffeine, and barbiturates 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, aspirin, and caffeine capsules, 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. In patients receiving concomitant corticosteroids and chronic use of aspirin, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance. Butalbital, aspirin, and caffeine capsules may enhance the effects of:
Oral anticoagulants, causing bleeding by inhibiting prothrombin formation in the liver and displacing anticoagulants from plasma protein binding sites.
Oral antidiabetic agents and insulin, causing hypoglycemia by contributing an additive effect, if dosage of butalbital, aspirin, and caffeine capsules exceeds maximum recommended daily dosage.
6-mercaptopurine and methotrexate, causing bone marrow toxicity and blood dyscrasias by displacing these drugs from secondary binding sites, and, in the case of methotrexate, also reducing its excretion.
Non-steroidal anti-inflammatory agents, increasing the risk of peptic ulceration and bleeding by contributing additive effects.
Other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression. Butalbital, aspirin, and caffeine capsules may diminish the effects of:
Uricosuric agents such as probenecid and sulfinpyrazone, reducing their effectiveness in the treatment of gout. Aspirin competes with these agents for protein binding sites.

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.

The toxic effects of acute overdosage of butalbital, aspirin, and caffeine capsules are attributable mainly to its barbiturate component, and, to a lesser extent, aspirin.
Because toxic effects of caffeine occur in very high dosages only, the possibility of significant caffeine toxicity from butalbital, aspirin, and caffeine capsules overdosage is unlikely.
Signs and Symptoms Symptoms attributable to acute barbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; hypovolemic shock.
Symptoms attributable to acute aspirin poisoning include hyperpnea; acid-base disturbances with development of metabolic acidosis; vomiting and abdominal pain; tinnitus; hyperthermia; hypoprothrombinemia; restlessness; delirium; convulsions.
Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium; tachycardia and extrasystoles.
Treatment Treatment consists primarily of management of barbiturate intoxication and the correction of the acid-base imbalance due to salicylism.
Vomiting should be induced mechanically or with emetics in the conscious patient.
Gastric lavage may be used if the pharyngeal and laryngeal reflexes are present and if less than 4 hours have elapsed since ingestion.
A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and when necessary to provide assisted respiration.
Diuresis, alkalinization of the urine, and correction of electrolyte disturbances should be accomplished through administration of intravenous fluids such as 1% sodium bicarbonate in 5% dextrose in water.
Meticulous attention should be given to maintaining adequate pulmonary ventilation.
The value of vasopressor agents such as Norepinephrine or Phenylephrine Hydrochloride in treating hypotension is questionable since they increase vasoconstriction and decrease blood flow.
However, if prolonged support of blood pressure is required, Norepinephrine Bitartrate (Levophed ® ) may be given I.V. with the usual precautions and serial blood pressure monitoring.
In severe cases of intoxication, peritoneal dialysis, hemodialysis, or exchange transfusion may be lifesaving.
Hypoprothrombinemia should be treated with Vitamin K, intravenously.
Up-to-date information about the treatment of overdose can often be obtained from a Certified Regional Poison Control Center.
Telephone numbers of Certified Regional Poison Control Centers are listed in the Physicians' Desk Reference ® .
Toxic and Lethal Doses (for
adults) Butalbital:
toxic dose 1 g (20 capsules) Aspirin:
toxic blood level greater than 30 mg/100 mL; lethal dose 10 to 30 g Caffeine:
toxic dose 1 g (25 capsules)

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Controlled Substance Butalbital, aspirin, and caffeine capsules are controlled by the Drug Enforcement Administration and are classified under Schedule III.
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 1,500 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.
Butalbital, aspirin, and caffeine capsules are controlled by the Drug Enforcement Administration and are classified under Schedule III.
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 1,500 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 pediatric patients have not been established.

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

Side effects

The most frequent adverse reactions are drowsiness and dizziness.
Less frequent adverse reactions are lightheadedness and gastrointestinal disturbances including nausea, vomiting, and flatulence.
A single incidence of bone marrow suppression has been reported with the use of butalbital, aspirin, and caffeine capsules.
Several cases of dermatological reactions including toxic epidermal necrolysis and erythema multiforme have been reported.
Butalbital, aspirin, and caffeine capsules may also cause exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and fixed drug eruption (FDE) ( see WARNINGS ).

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

What to discuss with your doctor

Patients should be informed that butalbital, aspirin, and caffeine capsules contain aspirin and should not be taken by patients with an aspirin allergy.
Serious Skin Reactions, including DRESS Advise patients to stop taking butalbital, aspirin, and caffeine capsules immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [ see WARNINGS ].
Butalbital, aspirin, and caffeine capsules may impair the mental and/or physical abilities required for performance of potentially hazardous tasks such as driving a car or operating machinery.
Such tasks should be avoided while taking butalbital, aspirin, and caffeine capsules.
Alcohol and other CNS depressants may produce an additive CNS depression when taken with butalbital, aspirin, and caffeine capsules 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.
Pregnancy Embryo-Fetal Toxicity Inform pregnant women to
avoid use of aspirin and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus.
If treatment with butalbital, aspirin, and caffeine capsules is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [ see WARNINGS;
Fetal Toxicity , PRECAUTIONS;
Pregnancy ].

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

What it looks like and how it is packed

Butalbital, aspirin, and caffeine capsules, USP are green and light green in color, imprinted with “SANDOZ” on the cap and “1552” on the body.
Each capsule contains:
butalbital USP, 50 mg; aspirin USP, 325 mg; caffeine USP, 40 mg and is available as follows:
Bottles of 100 NDC 0781-2270-01 Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from moisture.
For all medical inquiries contact:
Sandoz Inc. 1-800-525-8747 Manufactured by Lannett Company, Inc. for Sandoz Inc., Princeton, NJ 08540 All trademarks are the property of their respective owners.
Rev. 12/2024

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

What is in it

Butalbital, aspirin, and caffeine capsules, USP are supplied in capsule form for oral administration.
Each capsule contains the following active ingredients:
butalbital, USP 50 mg aspirin, USP 325 mg caffeine, USP 40 mg Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate.
It has the following Molecular Formula: C 11 H 16 N 2 O 3 Molecular Weight:
224.26 Structural Formula:
Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory.
It has the following Molecular Formula: C 9 H 8 O 4 Molecular Weight:
180.16 Structural Formula:
Caffeine (1, 3, 7-trimethylxanthine) is a central nervous system stimulant.
It has the following Molecular Formula: C 8 H 10 N 4 O 2 Molecular Weight:
194.19 Structural Formula:
Inactive Ingredients:
pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, trimyristin, talc, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Green No. 3, and gelatin.
The capsule imprinting ink contains:
shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and D&C Yellow No.10 Aluminum Lake. butalbital-chemical-structure aspirin-chemical-structure caffeine-chemical-structure

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 No. 10; FD&C Green No. 3Some people react to dyes such as tartrazine (Yellow 5) or carmine.
GelatingelatinAnimal-derived: matters for vegetarian, vegan, halal and kosher diets.

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 (4)

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

Showing 4 of 4

Details

Made by	Sandoz Inc
Active substance	Butalbital, Aspirin, and Caffeine
Used in	Breathing, airways, allergies and cough
Strength	50 mg + 325 mg + 40 mg
Form	Capsule
Route	Oral
Packs	100 CAPSULE in 1 BOTTLE
NDC	0781-2270

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

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

Capsule5 products
- 50 mg + 325 mg + 40 mg4
  50 mg + 325 mg + 40 mg · 4 companies
  - Chartwell RX, LLC
  - Lannett Company, Inc.
  - Sandoz Inc · this page
  - Westminster Pharmaceuticals, LLC
- 50 mg + 500 mg + 40 mg

Same active substance

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

See every product with Butalbital, Aspirin, and Caffeine