DailyMed Label: BUPAP

DailyMed Label: BUPAP

2020

DailyMed Prescription

BUPAP

Butalbital and Acetaminophen Tablets

Bausch Health US, LLC

NDC: 0095-3000

NDC: 0095-3000

NDC: 0095-3000

Each BUPAP Tablet for oral administration, contains Butalbital, USP 50 mg and Acetaminophen, USP 300 mg. In addition, each BUPAP Tablet contains the following inactive ingredients: Pregelatinized Starch, Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, D&C Yellow #10 Lake, and FD&C Red #40 Lake. 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: 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.jpg APAP Molecule

BUPAP 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.

BUPAP Tablets: one or two tablets every four hours. Total daily dosage should not exceed 6 tablets. Extended and repeated use of these products is not recommended because of the potential for physical dependence.

This product is contraindicated under the following conditions: • Hypersensitivity or intolerance to any component of this product. • Patients with porphyria.

BUPAP Tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions. This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product. Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided. Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed. • Do not take BUPAP Tablets if you are allergic to any of its ingredients. • If you develop signs of allergy such as a rash or difficulty breathing stop taking BUPAP Tablets and contact your healthcare provider immediately. • Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose. In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests. 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. Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid. No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility. Pregnancy Category C: Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital and acetaminophen can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. These products should be given to a pregnant woman only when clearly needed. Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last two months of pregnancy. Butalbital was found in the infant's serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms. Barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Safety and effectiveness in children below the age of 12 have not been established.

Frequently Observed: The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.

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.

Yellowish round, unscored tablets with BA 300 on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA BUPAP is a trademark of Bausch Health Companies Inc. or its affiliates. © 2020 Bausch Health Companies Inc. or its affiliates 7075 9417104 Rev. 04/2020

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. Pharmacokinetics: The behavior of the individual components is described below. Butalbital: Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility. Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2,3-dihydroxy-propyl) barbituric acid (about 24% of the dose), 5-allyl-5 (3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated. See OVERDOSAGE for toxicity information. Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See OVERDOSAGE for toxicity information.

NDC 0095-3000-01 Rx only BUPAP ® (Butalbital and Acetaminophen) Tablets 50 mg/300 mg Each Tablet Contains: Butalbital, USP* …… 50 mg *Warning: May be habit-forming Acetaminophen, USP …… 300 mg BAUSCH HEALTH 100 Tablets DISPLAY PANEL-100 Tablets label