Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg Tablet containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Available as white to off-white round tablets, debossed "BAC" on one side and debossed "123" on the other side. • Bottles of 30 tablets (NDC 71205-981-30) • Bottles of 60 tablets (NDC 71205-981-60) • Bottles of 90 tablets (NDC 71205-981-90) • Bottles of 100 tablets (NDC 71205-981-00) • Bottles of 120 tablets (NDC 71205-981-72) • Bottles of 500 tablets (NDC 71205-981-55) Store at 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]; dispense in a tight, light resistant container as directed in the USP.; PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label NDC 71205-981-30 R x Only Butalbital, Acetaminophen, and Caffeine Tablets, USP Each Tablet Contains: Butalbital, USP 50 mg Acetaminophen, USP 325 mg Caffeine, USP 40 mg 30 Tablets 71205-981-30
- HOW SUPPLIED Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg Tablet containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Available as white to off-white round tablets, debossed "BAC" on one side and debossed "123" on the other side. • Bottles of 30 tablets (NDC 71205-981-30) • Bottles of 60 tablets (NDC 71205-981-60) • Bottles of 90 tablets (NDC 71205-981-90) • Bottles of 100 tablets (NDC 71205-981-00) • Bottles of 120 tablets (NDC 71205-981-72) • Bottles of 500 tablets (NDC 71205-981-55) Store at 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]; dispense in a tight, light resistant container as directed in the USP.
- PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label NDC 71205-981-30 R x Only Butalbital, Acetaminophen, and Caffeine Tablets, USP Each Tablet Contains: Butalbital, USP 50 mg Acetaminophen, USP 325 mg Caffeine, USP 40 mg 30 Tablets 71205-981-30
Overview
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: silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula: C11H16N2O3 M.W. 224.26 Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula: C8H10N4O2 M.W. 194.19 Chemical Structure Chemical Structure Chemical Structure
Indications & Usage
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 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 & Administration
One or two tablets every four 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.
Warnings & Precautions
WARNINGS Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well. Serious skin reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious 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, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Butalbital, Acetaminophen and Caffeine Tablets, USP for patients with acetaminophen allergy. Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
Boxed Warning
BOXED WARNING Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
Contraindications
This product is contraindicated under the following conditions: • Hypersensitivity or intolerance to any component of this product • Patients with porphyria.
Adverse Reactions
Frequently Observed The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling. Infrequently Observed All adverse events tabulated below are classified as infrequent. Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement, or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital. Autonomic Nervous System: dry mouth, hyperhidrosis. Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation. Cardiovascular: tachycardia. Musculoskeletal: leg pain, muscle fatigue. Genitourinary: diuresis. Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions. Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported. The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in the OVERDOSAGE section. Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis. Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia. To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
Storage & Handling
Store at 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]; dispense in a tight, light resistant container as directed in the USP.
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