Butisol Sodium (Butabarbital Elixir)

• It is used to treat sleep problems.
• It may be given to you for other reasons. Talk with the doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert after you take Butisol Sodium. You may still feel sleepy the day after you take this medicine. Avoid these tasks or actions until you feel fully awake.
• Have your blood work checked if you are on Butisol Sodium for a long time. Talk with your doctor.
• This medicine may be habit-forming with long-term use.
• When sleep drugs are used nightly for more than a few weeks, they may not work as well to help sleep problems. This is known as tolerance. Only use sleep drugs for a short time. If sleep problems last, call the doctor.
• Do not take this medicine for longer than you were told by your doctor.
• If you have been taking Butisol Sodium for many weeks, talk with your doctor before stopping. You may want to slowly stop this medicine.
• Avoid alcohol while taking Butisol Sodium. Do not take this medicine if you drank alcohol that evening or before bed.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Some people have done certain tasks or actions while they were not fully awake like driving, making and eating food, and having sex. Most of the time, people do not remember doing these things. Tell your doctor if this happens to you.
• If you are allergic to tartrazine, talk with your doctor. Some products have tartrazine.
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking Butisol Sodium with your other drugs.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Butisol Sodium (butabarbital elixir).
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Dizziness.
• Feeling sleepy the next day.
• Upset stomach or throwing up.
• Hard stools (constipation).
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.