Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Butalbital, Acetaminophen and Caffeine Tablets, USP containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine is available as white to off-white, round shaped, biconvex tablets, debossed "C17" on one side and plain on the other. NDC: 71335-9603-1: 20 Tablets in a BOTTLE NDC: 71335-9603-2: 30 Tablets in a BOTTLE NDC: 71335-9603-3: 60 Tablets in a BOTTLE NDC: 71335-9603-4: 90 Tablets in a BOTTLE NDC: 71335-9603-5: 50 Tablets in a BOTTLE NDC: 71335-9603-6: 6 Tablets in a BOTTLE NDC: 71335-9603-7: 120 Tablets in a BOTTLE NDC: 71335-9603-8: 40 Tablets in a BOTTLE NDC: 71335-9603-9: 12 Tablets in a BOTTLE NDC: 71335-9603-0: 84 Tablets in a BOTTLE Store and Dispense Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]; dispense in a tight, light-resistant container as defined in the USP. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504; Butalbital,APAP, Caf 50/325/40 (CIII)Tab Label
- HOW SUPPLIED Butalbital, Acetaminophen and Caffeine Tablets, USP containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine is available as white to off-white, round shaped, biconvex tablets, debossed "C17" on one side and plain on the other. NDC: 71335-9603-1: 20 Tablets in a BOTTLE NDC: 71335-9603-2: 30 Tablets in a BOTTLE NDC: 71335-9603-3: 60 Tablets in a BOTTLE NDC: 71335-9603-4: 90 Tablets in a BOTTLE NDC: 71335-9603-5: 50 Tablets in a BOTTLE NDC: 71335-9603-6: 6 Tablets in a BOTTLE NDC: 71335-9603-7: 120 Tablets in a BOTTLE NDC: 71335-9603-8: 40 Tablets in a BOTTLE NDC: 71335-9603-9: 12 Tablets in a BOTTLE NDC: 71335-9603-0: 84 Tablets in a BOTTLE Store and Dispense Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]; dispense in a tight, light-resistant container as defined in the USP. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
- Butalbital,APAP, Caf 50/325/40 (CIII)Tab Label
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: colloidal silicon dioxide, croscarmellose sodium, 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: Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula:
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 2 tablets every 4 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
– 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 KVK-Tech, Inc. at 1-215-579-1842 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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