Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Butalbital, Acetaminophen, and Caffeine Capsules USP, 50 mg/300 mg/40 mg Containing: 50 mg butalbital (WARNING: May be habit-forming.), 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a blue opaque cap and a blue opaque body imprinted with T26 on both cap and body in red, filled with white to off-white powder. The capsules are supplied in bottles of 100 capsules (NDC 70752-144-10) and 500 capsules (NDC 70752-144-14). Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.; PRINCIPAL DISPLAY PANEL NDC 70752- 144 -10 Butalbital, Acetaminophen and Caffeine Capsules USP 50 mg/300 mg/40 mg 100 Capsules Rx only PRINCIPAL DISPLAY PANEL NDC 70752- 144- 14 Butalbital, Acetaminophen and Caffeine Capsules USP 50 mg/300 mg/40 mg 500 Capsules Rx only container100cc container500cc
- HOW SUPPLIED Butalbital, Acetaminophen, and Caffeine Capsules USP, 50 mg/300 mg/40 mg Containing: 50 mg butalbital (WARNING: May be habit-forming.), 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a blue opaque cap and a blue opaque body imprinted with T26 on both cap and body in red, filled with white to off-white powder. The capsules are supplied in bottles of 100 capsules (NDC 70752-144-10) and 500 capsules (NDC 70752-144-14). Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.
- PRINCIPAL DISPLAY PANEL NDC 70752- 144 -10 Butalbital, Acetaminophen and Caffeine Capsules USP 50 mg/300 mg/40 mg 100 Capsules Rx only PRINCIPAL DISPLAY PANEL NDC 70752- 144- 14 Butalbital, Acetaminophen and Caffeine Capsules USP 50 mg/300 mg/40 mg 500 Capsules Rx only container100cc container500cc
Overview
Butalbital, Acetaminophen and Caffeine Capsules USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients: butalbital USP……………………50 mg WARNING: May be habit-forming. acetaminophen USP…………….300 mg caffeine USP……………………..40 mg Inactive Ingredients: D&C yellow #10, FD&C blue #1, FD&C red #3, gelatin, microcrystalline cellulose, stearic acid, talc and titanium dioxide. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula: Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula: Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula: chemsture-butalbital chemsture-acetaminophen chemsture-ceffeine
Indications & Usage
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 & Administration
One or 2 capsules every 4 hours as needed. 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.
Warnings & Precautions
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 maybe 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, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Butalbital, Acetaminophen and Caffeine Capsules. USP for patients with acetaminophen allergy.
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 EVENTS, contact Quagen Pharmaceuticals LLC at 1-888-344-9603 or www.quagenpharma.com, 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.
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