ARIPIPRAZOLE- aripiprazole tablet 
XLCare Pharmaceuticals, Inc.

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MEDICATION GUIDE

Aripiprazole Tablets USP

(ar'' i pip' ra zole)

What is the most important information I should know about aripiprazole tablets?

(For other side effects, also see “What are the possible side effects of aripiprazole tablets?”)

Serious side effects may happen when you take aripiprazole tablets, including:

Increased risk of death in elderly patients with dementia-related psychosis: Medicines like aripiprazole tablets can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Aripiprazole tablets are not approved for the treatment of patients with dementia-related psychosis.

Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:

1.      Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2.      Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) suicidal thoughts or actions.

3.      How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

What else do I need to know about antidepressant medicines?

What are aripiprazole tablets?

It is not known if aripiprazole tablets are safe or effective in children:

Do not take aripiprazole tablets if you are allergic to aripiprazole or any of the ingredients in aripiprazole tablets. See the end of this Medication Guide for a complete list of ingredients in aripiprazole tablets.

Before taking aripiprazole tablets, tell your healthcare provider about all your medical conditions, including if you have or had:

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Aripiprazole tablets and other medicines may affect each other causing possible serious side effects. Aripiprazole tablets may affect the way other medicines work, and other medicines may affect how aripiprazole tablets works.

Your healthcare provider can tell you if it is safe to take aripiprazole tablets with your other medicines. Do not start or stop any medicines while taking aripiprazole tablets without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

How should I take aripiprazole tablets?

What should I avoid while taking aripiprazole tablets?

What are the possible side effects of aripiprazole tablets?

Aripiprazole tablets may cause serious side effects, including:

Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving aripiprazole tablets:

If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.

The most common side effects of aripiprazole tablets in adults include:

  • Nausea
  • vomiting
  • constipation
  • headache
  • blurred vision
  • upper respiratory illness
  • dizziness
  • anxiety
  • insomnia
  • restlessness
  • inner sense of restlessness/need to move (akathisia)

The most common side effects of aripiprazole tablets in children include:

  • feeling sleepy
  • headache
  • vomiting
  • fatigue
  • increased or decreased appetite
  • increased saliva or drooling
  • insomnia
  • nausea
  • stuffy nose
  • weight gain
  • uncontrolled movement such as restlessness, tremor
  • muscle stiffness

These are not all the possible side effects of aripiprazole tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store aripiprazole tablets?

Keep aripiprazole tablets and all medicines out of the reach of children.

General information about the safe and effective use of aripiprazole tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use aripiprazole tablets for a condition for which it was not prescribed. Do not give aripiprazole tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about aripiprazole tablets that was written for healthcare professionals.

For more information, call 1-866-495-1995.

What are the ingredients in aripiprazole tablets?

Active ingredient: aripiprazole USP

Inactive ingredients: corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose

Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

Manufactured for:

XLCare Pharmaceuticals, Inc.

242 South Culver Street, Suite 202

Lawrenceville, GA 30046

Manufactured by:

Ascent Pharmaceuticals, Inc.

Central Islip, NY 11722

This Medication Guide has been approved by the U.S. Food and Drug Administration

Revised: 10/20

Revised: 1/2021
XLCare Pharmaceuticals, Inc.