BUTALBITAL AND ACETAMINOPHEN
(+1 other brands)
Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Butalbital and Acetaminophen, 50 mg/ 325 mg: White, capsule shaped tablet debossed “LL 721” on one side and plain on the other, in bottles of 30 tablets (NDC 68047-721-30), and 100 tablets (NDC 68047-721-01). Butalbital and Acetaminophen, 25 mg / 325 mg: White, capsule shaped tablet debossed “LL 722” on one side and plain on the other, in bottles of 30 tablets (NDC 68047-753-30) and 100 tablets (NDC 68047-753-01). ALLZITAL (butalbital and acetaminophen, 25 mg / 325 mg): White, capsule shaped tablet debossed “LL 722” on one side and plain on the other, in bottles of 30 tablets (NDC 68047-752-30) and 100 tablets (NDC 68047-752-01). Storage: Protect from light and moisture. Store Butalbital and Acetaminophen tablets at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). Dispense in a tight, light-resistant container with a child-resistant closure. Distributed by: Larken Laboratories, Inc. Canton, MS 39046 www.larkenlabs.com Rev. 06/2022 500411-07; CONTAINER LABELS NDC 68047-721-01 Butalbital and Acetaminophen 50 mg/ 325 mg tablets Each white capsule shaped tablet debossed “LL 721” on one side and plain on the other side contains: Butalbital, USP 50 mg Acetaminophen, USP 325 mg Rx only 100 Tablets Butalbital and Acetaminophen 50 mg 325 mg label; NDC 68047-753-01 Butalbital and Acetaminophen, 25 mg/ 325 mg tablets Each white capsule shaped tablet debossed “LL 722” on one side and plain on the other side contains: Butalbital, USP 25 mg Acetaminophen, USP 325 mg Rx only 100 Tablets Butalbital and Acetaminophen 25 mg 325 mg label; NDC 68047-752-01 ALLZITAL (butalbital and acetaminophen, 25 mg/ 325) mg tablets Each white capsule shaped tablet debossed “LL 722” on one side and plain on the other side contains: Butalbital, USP 25 mg Acetaminophen, USP 325 mg Rx only 100 Tablets ALLZITAL (butalbital and acetaminophen 25 mg 325 mg) label
- HOW SUPPLIED Butalbital and Acetaminophen, 50 mg/ 325 mg: White, capsule shaped tablet debossed “LL 721” on one side and plain on the other, in bottles of 30 tablets (NDC 68047-721-30), and 100 tablets (NDC 68047-721-01). Butalbital and Acetaminophen, 25 mg / 325 mg: White, capsule shaped tablet debossed “LL 722” on one side and plain on the other, in bottles of 30 tablets (NDC 68047-753-30) and 100 tablets (NDC 68047-753-01). ALLZITAL (butalbital and acetaminophen, 25 mg / 325 mg): White, capsule shaped tablet debossed “LL 722” on one side and plain on the other, in bottles of 30 tablets (NDC 68047-752-30) and 100 tablets (NDC 68047-752-01). Storage: Protect from light and moisture. Store Butalbital and Acetaminophen tablets at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). Dispense in a tight, light-resistant container with a child-resistant closure. Distributed by: Larken Laboratories, Inc. Canton, MS 39046 www.larkenlabs.com Rev. 06/2022 500411-07
- CONTAINER LABELS NDC 68047-721-01 Butalbital and Acetaminophen 50 mg/ 325 mg tablets Each white capsule shaped tablet debossed “LL 721” on one side and plain on the other side contains: Butalbital, USP 50 mg Acetaminophen, USP 325 mg Rx only 100 Tablets Butalbital and Acetaminophen 50 mg 325 mg label
- NDC 68047-753-01 Butalbital and Acetaminophen, 25 mg/ 325 mg tablets Each white capsule shaped tablet debossed “LL 722” on one side and plain on the other side contains: Butalbital, USP 25 mg Acetaminophen, USP 325 mg Rx only 100 Tablets Butalbital and Acetaminophen 25 mg 325 mg label
- NDC 68047-752-01 ALLZITAL (butalbital and acetaminophen, 25 mg/ 325) mg tablets Each white capsule shaped tablet debossed “LL 722” on one side and plain on the other side contains: Butalbital, USP 25 mg Acetaminophen, USP 325 mg Rx only 100 Tablets ALLZITAL (butalbital and acetaminophen 25 mg 325 mg) label
Overview
Each Butalbital and Acetaminophen 50 mg/ 325 mg tablet for oral administration contains: Butalbital, USP ………...….. 50 mg Acetaminophen, USP ……. 325 mg Each Butalbital and Acetaminophen 25 mg/ 325 mg tablet for oral administration contains: Butalbital, USP ………...….. 25 mg Acetaminophen, USP ……. 325 mg Each ALLZITAL (butalbital and acetaminophen 25 mg/ 325 mg) tablet for oral administration contains: Butalbital, USP ………...….. 25 mg Acetaminophen, USP ……. 325 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. 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: C 11 H 16 N 2 O 3 M.W. = 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: C 8 H 9 NO 2 M.W. = 151.16 butalbital structure acetaminophen structure
Indications & Usage
Butalbital and Acetaminophen 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
Butalbital and Acetaminophen, 50 mg/ 325 mg tablets: One or two tablets every four hours as needed. Do not exceed not exceed 6 tablets per day. Butalbital and Acetaminophen, 25 mg/ 325 mg tablets: Two tablets every four hours. Total daily dosage should not exceed 12 tablets. ALLZITAL (butalbital and acetaminophen, 25 mg / 325 mg): Two tablets every four hours. Total daily dosage should not exceed 12 tablets. Extended and repeated use of these products 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 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 and Acetaminophen tablets immediately and seek medical care if they experience these symptoms. Do not prescribe Butalbital and Acetaminophen tablets for patients with acetaminophen allergy.
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 4,000 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. To report SUSPECTED ADVERSE REACTIONS, contact Larken Laboratories, Inc. at 1-601-855-7678 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 and acetaminophen 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
Storage: Protect from light and moisture. Store Butalbital and Acetaminophen tablets at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). Dispense in a tight, light-resistant container with a child-resistant closure. Distributed by: Larken Laboratories, Inc. Canton, MS 39046 www.larkenlabs.com Rev. 06/2022 500411-07
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