Butalbital, Acetaminophen And Caffeine

Tablet · Oral

Prescription (Rx) Barbiturate Central Nervous System Stimulant Methylxanthine

Boxed warning. 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.

Uses

Butalbital, acetaminophen, 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 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

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

Contraindications

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

Warnings

Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended. 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 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 capsules immediately and seek medical care if they experience these symptoms. Do not prescribe butalbital, acetaminophen, and caffeine capsules for patients with acetaminophen allergy.

Precautions

General Butalbital, acetaminophen, and caffeine capsules 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 Do not take butalbital, acetaminophen, and caffeine capsules 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 capsules 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. 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. 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 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. 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 capsules 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.

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.

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.

Pregnancy

Pregnancy Teratogenic Effects 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 capsules 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

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, delirium, tachycardia and extrasystoles. Treatment A single or multiple drug overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered. Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration. Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

Description

Butalbital, acetaminophen, and caffeine capsules are supplied in hard-gelatin capsule form for oral administration. Each capsule contains: Butalbital, USP Warning: May be habit-forming. 50 mg Acetaminophen, USP 300 mg Caffeine, USP 40 mg In addition, each capsule contains the following inactive ingredients: microcrystalline cellulose, povidone, stearic acid and talc with capsule shell composed of FD&C blue 1, FD&C red 40, gelatin, sodium lauryl sulfate and titanium dioxide. 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: Butalbital C 11 H 16 N 2 O 3 MW: 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: Acetaminophen C 8 H 9 NO 2 MW: 151.16 Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula: Caffeine C 8 H 10 N 4 O 2 MW: 194.19 Chemical Structure Chemical Structure Chemical Structure

How supplied

Butalbital, acetaminophen, and caffeine capsules containing butalbital 50 mg (Warning: May be habit-forming) , acetaminophen 300 mg and caffeine 40 mg, are supplied in bottles of 100 capsules, NDC 51672-4222-1. Capsules are light blue gelatin capsule, size 0, with "TARO" over "ABC" printed in black ink on cap and body. Store at 20 ° to 25 ° C (68 ° to 77 ° F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

Storage

Store at 20 ° to 25 ° C (68 ° to 77 ° F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

Patient information

Information for Patients/Caregivers Do not take butalbital, acetaminophen, and caffeine capsules 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 capsules 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. 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.

Label text from the FDA structured product label by Sun Pharmaceutical Industries, Inc. (revised Jul 14, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Butalbital in 51 products
Acetaminophen in 51 products
Caffeine in 51 products

Butalbital, Acetaminophen And Caffeine NDC products (51)

NDC	Strength & form	Labeler	Type
50090-7519	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	A-S Medication Solutions	ANDA · DEA CIII
0591-2640	Butalbital 50 mg/1; Acetaminophen 300 mg/1; Caffeine 40 mg/1 Capsule	Actavis Pharma, Inc.	ANDA
0591-3369	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Actavis Pharma, Inc.	ANDA
80425-0567	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Advanced Rx of Tennessee, LLC	ANDA · DEA CIII
80425-0497	Butalbital 50 mg/1; Acetaminophen 300 mg/1; Caffeine 40 mg/1 Capsule	Advanced Rx of Tennessee, LLC	ANDA · DEA CIII
69292-305	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Capsule	Amici Pharma, Inc.	ANDA · DEA CIII
13107-075	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Capsule	Aurolife Pharma, LLC	ANDA · DEA CIII
42291-181	Butalbital 50 mg/1; Acetaminophen 300 mg/1; Caffeine 40 mg/1 Capsule	AvKARE	ANDA · DEA CIII
63629-2372	Acetaminophen 300 mg/1; Caffeine 40 mg/1; Butalbital 50 mg/1 Capsule	Bryant Ranch Prepack	ANDA · DEA CIII
63629-2087	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Capsule	Bryant Ranch Prepack	ANDA · DEA CIII
63629-8392	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Bryant Ranch Prepack	ANDA · DEA CIII
71335-2270	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Bryant Ranch Prepack	ANDA · DEA CIII
71335-2272	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Bryant Ranch Prepack	ANDA · DEA CIII
71335-2546	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Bryant Ranch Prepack	ANDA · DEA CIII
71335-2630	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Bryant Ranch Prepack	ANDA · DEA CIII
71335-9603	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Bryant Ranch Prepack	ANDA · DEA CIII
72162-1096	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Capsule	Bryant Ranch Prepack	ANDA · DEA CIII
72162-1232	Acetaminophen 300 mg/1; Caffeine 40 mg/1; Butalbital 50 mg/1 Capsule	Bryant Ranch Prepack	ANDA · DEA CIII
72162-2665	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Capsule	Bryant Ranch Prepack	ANDA · DEA CIII
72162-2666	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Bryant Ranch Prepack	ANDA · DEA CIII
55154-3356	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Cardinal Health 107, LLC	ANDA · DEA CIII
62135-751	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Chartwell RX, LLC	ANDA · DEA CIII
75907-009	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Capsule	Dr. Reddy's Labratories Inc.	ANDA · DEA CIII
64950-290	Butalbital 50 mg/15mL; Acetaminophen 325 mg/15mL; Caffeine 40 mg/15mL Solution	Genus Lifesciences Inc.	ANDA · DEA CIII
51407-556	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Golden State Medical Supply, Inc.	ANDA · DEA CIII
70010-149	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Granules Pharmaceuticals Inc.	ANDA · DEA CIII
70010-044	Butalbital 50 mg/1; Acetaminophen 300 mg/1; Caffeine 40 mg/1 Capsule	Granules Pharmaceuticals Inc.	ANDA
10702-253	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	KVK-Tech, Inc.	ANDA · DEA CIII
0527-1695	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Lannett Company, Inc.	ANDA · DEA CIII
0527-4094	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Capsule	Lannett Company, Inc.	ANDA
0527-4095	Butalbital 50 mg/1; Acetaminophen 300 mg/1; Caffeine 40 mg/1 Capsule	Lannett Company, Inc.	ANDA
79739-7320	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	LGM PHARMA SOLUTIONS, LLC	ANDA · DEA CIII
0904-6938	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Major Pharmaceuticals	ANDA · DEA CIII
46672-053	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Mikart, LLC	ANDA · DEA CIII
68071-3249	Acetaminophen 325 mg/1; Butalbital 50 mg/1; Caffeine 40 mg/1 Tablet	NuCare Pharmaceuticals, Inc.	ANDA · DEA CIII
68788-8794	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Preferred Pharmaceuticals Inc.	ANDA · DEA CIII
68788-4126	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Preferred Pharmaceuticals Inc.	ANDA · DEA CIII
63187-520	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Proficient Rx LP	ANDA · DEA CIII
63187-933	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Proficient Rx LP	ANDA · DEA CIII
70752-144	Butalbital 50 mg/1; Acetaminophen 300 mg/1; Caffeine 40 mg/1 Capsule	QUAGEN PHARMACEUTICALS LLC	ANDA · DEA CIII
70752-142	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	QUAGEN PHARMACEUTICALS LLC	ANDA · DEA CIII
70752-141	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Capsule	QUAGEN PHARMACEUTICALS LLC	ANDA · DEA CIII
67296-2204	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	Redpharm Drug	ANDA · DEA CIII
70518-4601	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	REMEDYREPACK INC.	ANDA · DEA CIII
70518-1134	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	REMEDYREPACK INC.	ANDA · DEA CIII
13925-536	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Capsule	Seton Pharmaceuticals LLC	ANDA · DEA CIII
13925-535	Butalbital 50 mg/1; Acetaminophen 300 mg/1; Caffeine 40 mg/1 Capsule	Seton Pharmaceuticals LLC	ANDA · DEA CIII
43547-686	Butalbital 50 mg/1; Acetaminophen 300 mg/1; Caffeine 40 mg/1 Capsule	SOLCO HEALTHCARE US, LLC	ANDA · DEA CIII
60760-865	Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 Tablet	ST. MARY'S MEDICAL PARK PHARMACY	ANDA · DEA CIII
51672-4222	Butalbital 50 mg/1; Acetaminophen 300 mg/1; Caffeine 40 mg/1 Capsule	Sun Pharmaceutical Industries, Inc.	ANDA · DEA CIII
11534-187	Acetaminophen 300 mg/1; Caffeine 40 mg/1; Butalbital 50 mg/1 Capsule	SUNRISE PHARMACEUTICAL, INC	ANDA · DEA CIII

Frequently asked questions

What is Butalbital, Acetaminophen And Caffeine used for?

What are the side effects of Butalbital, Acetaminophen And Caffeine?

Who makes Butalbital, Acetaminophen And Caffeine?

Butalbital, Acetaminophen And Caffeine is listed by 29 labelers in the FDA NDC directory, including A-S Medication Solutions, Actavis Pharma, Inc., Advanced Rx of Tennessee, LLC, Amici Pharma, Inc..