Uses of Haloperidol Oral Solution:

• It is used to treat Tourette's syndrome.
• It is used to treat problems with how one acts.
• It is used to treat mood problems.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Haloperidol Oral Solution?

• If you are allergic to haloperidol oral solution; any part of haloperidol oral solution; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have Parkinson's disease or dementia.
• If you are very sleepy.
• If you are breast-feeding. Do not breast-feed while you take haloperidol oral solution.

This is not a list of all drugs or health problems that interact with haloperidol oral solution.

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 haloperidol oral solution with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Haloperidol Oral Solution?

• Tell all of your health care providers that you take haloperidol oral solution. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how haloperidol oral solution affects you.
• Avoid drinking alcohol while taking haloperidol oral solution.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Sudden death and heartbeats that are not normal have happened with haloperidol oral solution. Very high doses raise the chance of these problems. Tell your doctor if you have a heartbeat that is not normal like long QT on ECG, electrolyte problems like low potassium or magnesium levels, heart problems, low thyroid function, or a family member that has a long QT on ECG. Tell your doctor if you take any drugs that may raise the chance of a heartbeat that is not normal. Ask your doctor if you are not sure. Talk with your doctor.
• A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
• If you also take lithium, talk with your doctor. A few people who were taking haloperidol oral solution along with lithium have had very bad side effects and brain problems that did not go away.
• Dizziness, sleepiness, and feeling less stable may happen with haloperidol oral solution. These may lead to falling, which can cause broken bones or other health problems.
• Some people have gotten pneumonia when taking haloperidol oral solution. Sometimes, this has been deadly. Call your doctor right away if you have fever, chest pain, cough, shortness of breath, or wheezing.
• Some people may get a severe muscle problem called tardive dyskinesia. This problem may lessen or go away after stopping haloperidol oral solution, but it may not go away. The risk is greater with diabetes and in older adults, especially older women. The risk is greater with longer use or higher doses, but it may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.
• If you are 65 or older, use haloperidol oral solution with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using haloperidol oral solution while you are pregnant.
• Taking haloperidol oral solution in the third trimester of pregnancy may lead to uncontrolled muscle movements and withdrawal in the newborn.

How is this medicine (Haloperidol Oral Solution) best taken?

Use haloperidol oral solution as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Measure liquid doses carefully. Use the measuring device that comes with haloperidol oral solution.
• You may take haloperidol oral solution without mixing, or you may mix with food or drink as you have been told.
• Keep taking haloperidol oral solution as you have been told by your doctor or other health care provider, even if you feel well.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Heat stroke has happened in people taking haloperidol oral solution. Be careful in hot weather and during physical activity.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• If you have been taking haloperidol oral solution on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking haloperidol oral solution all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.

What do I do if I miss a dose?

• 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.

What are some side effects that I need to call my doctor about right away?

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
• Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
• Shakiness, trouble moving around, or stiffness.
• Fast or abnormal heartbeat.
• Chest pain that is new or worse.
• Trouble passing urine.
• Feeling very tired or weak.
• Any unexplained bruising or bleeding.
• Change in eyesight.
• Hallucinations (seeing or hearing things that are not there).
• Seizures.
• Mental, mood, or behavior changes that are new or worse.
• Not able to control eye movements.
• Change in sex interest.
• Enlarged breasts, nipple discharge, not able to get or keep an erection (in males), or period (menstrual) changes (in females).
• Erection that lasts more than 4 hours.
• Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

What are some other side effects of Haloperidol Oral Solution?

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.
• Anxiety.
• Dry mouth.
• More saliva.
• Upset stomach or throwing up.
• Diarrhea or constipation.
• Headache.
• Not hungry.
• Restlessness.
• Trouble sleeping.
• Pimples (acne).

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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Haloperidol Oral Solution?

• Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.
• Do not freeze.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about haloperidol oral solution, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.