Ingredient Name: BUTALBITAL (byoo-TAL-bi-tal), ACETAMINOPHEN (a-seat-a-MIN-oh-fen) and CAFFEINE (kaf-EEN)

Drug Manufacturer: Shire US Inc

Common Uses: This medicine is a benzodiazepine used to treat seizures and panic disorder. It may also be used to treat other conditions as determined by your doctor.

Before Using This Medicine: Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking clozapine, disulfiram, rifampin, or nefazodone. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. TAKE THIS MEDICINE EVERY DAY at evenly spaced intervals. THIS MEDICINE MAY BE TAKEN WITH FOOD if it upsets your stomach. STORE THIS MEDICINE at room temperature, away from heat and light. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Cautions: IF TAKING THIS MEDICINE TO PREVENT SEIZURES, continue taking this medicine on a regular schedule. Do not stop taking this medicine without first checking with your doctor. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. If you are or may be pregnant, check with your doctor for instructions on using this medicine during pregnancy.

Possible Side Effects: SIDE EFFECTS, that may go away during treatment, include excessive daytime drowsiness, unusual weakness, dizziness, lightheadedness, headache, clumsiness, or unsteadiness. If they continue or are bothersome, check with your doctor. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Overdose: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include confusion, slow reflexes, clumsiness, deep sleep, and loss of consciousness.

Additional Information: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children