When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to butabarbital or to other barbiturates, you are pregnant, or you have porphyria.

How to Use This Medicine:
Tablet, Liquid

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• This medicine is not for long-term use.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• If you are taking this medicine for insomnia, it is best to take it at bedtime or when you are having trouble falling asleep.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines and foods can affect how butabarbital works. Tell your doctor if you are taking any of the following:
  
  • Blood thinner, such as warfarin
  • Doxycycline
  • Hormone medicines, such as estradiol, estrone, or progesterone
  • Griseofulvin
  • MAO inhibitor (MAOI)
  • Seizure medicine
  • Steroid medicine, such as dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Butabarbital may prevent birth control pills from working properly. To keep from getting pregnant, use an additional form of birth control with your pills.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, or severe pain in any part of your body. Also tell your doctor if you have severe depression, a history of drug addiction, or had thoughts of suicide.
• Some brands of butabarbital contain a yellow dye called tartrazine. Tartrazine may cause severe allergic reactions. Tell your doctor if you have any allergies.
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you. This medicine may also cause sleep-related behaviors such as driving, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away.
• Do not use this medicine to treat insomnia or other sleeping problems without checking with your doctor first. If you still have trouble sleeping after 7 to 10 days of using this medicine, check with your doctor.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Abnormal behavior or problems with speech
• Blistering, peeling, red skin rash
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Lightheadedness or fainting
• Severe confusion, drowsiness, or muscle weakness
• Shortness of breath or bluish skin
• Slow heartbeat

If you notice these less serious side effects, talk with your doctor:

• Confusion, nervousness, trouble sleeping, or unusual dreams
• Fever or headache
• Hallucinations (seeing or hearing things that are not there)
• Mild nausea or constipation

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088