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Follow the directions for using this medicine provided by your doctor. Wash and completely dry your hands before you take this medicine. Do not handle the tablet with wet or damp hands. Do not remove the tablet from the tablet pack until you are ready to take this medicine. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use. To remove this medicine from the tablet pack, firmly press and hold the thumb button, then pull out the tablet pack. Peel back the colored tab and gently remove the tablet. Do not push the tablet through the tablet pack. Do not cut or tear the tablet pack. DO NOT CHEW, CRUSH, OR SWALLOW this medicine. Place it under the tongue and allow it to completely dissolve. The tablet will dissolve within seconds. Do not eat, drink, or smoke while the tablet is dissolving. DO NOT EAT OR DRINK anything for 10 minutes after you take this medicine. After you have taken your dose, slide the tablet pack into the case until it clicks. STORE THIS MEDICINE at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), away from heat, moisture, and light. KEEP THIS MEDICINE out of the reach of children and away from pets. Take this medicine regularly to receive the most benefit from it. Taking this medicine at the same time each day will help you to remember. DO NOT SUDDENLY STOP TAKING THIS MEDICINE without checking with your doctor. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. 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.

IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms of overdose may include agitation, confusion, fainting, severe dizziness, or uncontrolled muscle movements.

WARNING: This medicine is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. This medicine is not approved to treat mental problems caused by dementia. Discuss any questions or concerns with your doctor. 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. DO NOT TAKE THIS MEDICINE if you are also taking antiarrhythmics (eg, amiodarone, sotalol, procainamide, quinidine), certain other antipsychotic medicines (eg, ziprasidone, chlorpromazine), citalopram, metoclopramide, phenothiazines (eg, thioridazine), quinolone antibiotics (eg, gatifloxacin, moxifloxacin), or any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking other prescription or nonprescription medicines (eg, used for allergies, cancer, depression or other mental or mood problems, high blood pressure, immune system suppression, infections, irregular heartbeat or other heart problems, narcotic or other substance abuse or dependence, nausea or vomiting, pain, reflux disease, seizures, stomach or bowel problems, Tourette syndrome), multivitamin products, or herbal or dietary supplements because they may interact with this medicine. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with this medicine. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including if you have a history of heart problems (eg, fast, slow, or irregular heartbeat; heart failure; ischemic heart disease), heart attack, low blood pressure, blood vessel problems, stroke, low white blood cell levels, liver problems, neuroleptic malignant syndrome (NMS), seizures, suicidal thoughts or attempts, alcohol abuse or dependence, Alzheimer disease, dementia, Parkinson disease, esophagus problems (eg, trouble swallowing), allergies, pregnancy, or breast-feeding. Tell your doctor if you are at risk for aspiration (inhaling foreign matter into the airways or lungs); if you have diabetes or are at risk for diabetes (eg, overweight, family history of diabetes); if you are dehydrated; have a low blood volume; drink alcohol; or will be exposed to very high or very low temperatures. Tell your doctor if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk for breast cancer. Tell your doctor if you have never taken an antipsychotic medicine before. You may be more likely to experience dizziness when you sit or stand up. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have severe liver problems, low blood potassium or magnesium levels, slow heartbeat, or a history of irregular heartbeat (eg, long QT syndrome, congenital prolongation of the QT interval). Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

SIDE EFFECTS that may occur while taking this medicine include dizziness; drowsiness; dry mouth; headache; indigestion; increased saliva production; increased appetite; joint aches; restlessness; taste changes; temporary numbness or tingling around the mouth; tiredness; trouble sleeping; upset stomach; vomiting; or weight gain. THIS MEDICINE MAY INCREASE the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms. CONTACT YOUR DOCTOR IMMEDIATELY if you experience change in the amount of urine produced; chest pain; fainting or loss of consciousness; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mouth blisters, sores, or irritation; muscle pain, weakness, or stiffness; new or worsening mental or mood changes (eg, aggression, agitation, depression, severe anxiety); seizures; severe or persistent dizziness or lightheadedness; shortness of breath; suicidal thoughts or actions; swelling of the hands, ankles, or feet; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; confusion; flushing; rapid breathing; fruit-like breath odor; weakness); trouble swallowing; uncontrolled muscle movements (eg, of the arms, legs, tongue, jaw, cheeks; tremors; twitching); or unusual sweating. AN ALLERGIC REACTION TO THIS MEDICINE IS UNLIKELY, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; or wheezing. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.