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 11H 16N 2O 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 8H 9NO 2 M.W. = 151.16

This combination drug product is intended as a treatment for tension headache.

It consists of a fixed combination of butalbital and acetaminophen. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.

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.

This product is contraindicated under the following conditions:

• Hypersensitivity or intolerance to any component of this product.
• Patients with porphyria.

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.

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

Abuse and Dependence: Butalbital: Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

Following an acute overdosage, toxicity may result from the barbiturate or the acetaminophen.

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 necrosis, 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.

Treatment: A single or multiple drug overdose with butalbital and acetaminophen 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.

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.

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).

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

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

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