Chloral Hydrate Capsules

• If you have an allergy to chloral hydrate or any other part of this medicine (chloral hydrate capsules).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Kidney disease, liver disease, esophagus problems, or stomach or bowel problems like swelling, ulcers, or irritation.
• If you have heart problems.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (chloral hydrate capsules) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine (chloral hydrate capsules) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

For all uses of this medicine:

• Take with or without food.
• If you are using this medicine (chloral hydrate capsules) to help you sleep, take it 15 to 30 minutes before bedtime.
• Take with a full glass of water.
• Swallow capsule whole. Do not chew, break, or crush.

For sleep:

• Do not take this medicine unless you can get a full night's sleep (at least 7 to 8 hours) before you need to be active again.

What do I do if I miss a dose?

For sleep:

• If you take this medicine (chloral hydrate capsules) on a regular basis, take a missed dose as soon as you think about it.
• If you will not be able to get a full night's sleep (at least 7 hours) after taking the missed dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

Before surgery:

• Call your doctor to find out what to do.

For other reasons:

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad belly pain.
• Change in balance.
• Feeling confused.
• Change in how you act.
• Hallucinations (seeing or hearing things that are not there).
• Fever or chills.
• Sore throat.
• Very bad dizziness or passing out.
• A heartbeat that does not feel normal.
• This medicine may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.
• 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.

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:

• Dizziness.
• Feeling sleepy the next day.
• Upset stomach or throwing up.
• Gas.
• Loose stools (diarrhea).
• Bad taste in your mouth.

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.