ARMODAFINIL- armodafinil tablet 
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Armodafinil Tablets, For Oral Use  CIV

(ar moe DAF i nil)

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

Armodafinil tablets are a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep armodafinil tablets in a safe place to prevent misuse and abuse. Selling or giving away armodafinil tablets may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Armodafinil tablets may cause serious side effects including a serious rash or a serious allergic reaction that may affect parts of your body such as your liver or blood cells. Any of these may need to be treated in a hospital and may be life-threatening.

Stop taking armodafinil tablets and call your doctor right away or get emergency help if you have any of these symptoms

If you have a severe rash with armodafinil tablets, stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured.

Armodafinil tablets are not approved for use in children for any medical condition.

It is not known if armodafinil tablets are safe and effective in children under the age of 18.

What are armodafinil tablets?

Armodafinil tablets are a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:

Armodafinil tablets will not cure these sleep disorders. Armodafinil tablets may help the sleepiness caused by these conditions, but it may not stop all your sleepiness. Armodafinil tablets do not take the place of getting enough sleep. Follow your doctor's advice about good sleep habits and using other treatments.

Do not take armodafinil tablets:

Before you take armodafinil tablets, tell your doctor about all of your medical conditions, including if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Armodafinil tablets and many other medicines can interact with each other, sometimes causing side effects. Armodafinil tablets may affect the way other medicines work, and other medicines may affect how armodafinil tablets work. Your dose of armodafinil tablets or certain other medicines may need to be changed.

Especially, tell your doctor if you use or take:

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. Your doctor or pharmacist will tell you if it is safe to take armodafinil tablets and other medicines together. Do not start any new medicines with armodafinil tablets unless your doctor has told you it is okay.

How should I take armodafinil tablets? 

Symptoms of an overdose of armodafinil tablets may include:

What should I avoid while taking armodafinil tablets?

What are the possible side effects of armodafinil tablets?

Armodafinil tablets
may cause serious side effects. Stop taking armodafinil tablets and call your doctor right away or get emergency help if you get any of the following:

The most common side effects of armodafinil tablets include:

These are not all the possible side effects of armodafinil 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 armodafinil tablets?

General information about the safe and effective use of armodafinil tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use armodafinil tablets for a condition for which it was not prescribed. Do not give armodafinil tablets to other people, even if they have the same symptoms that you have. It may harm them and is against the law. 

You can ask your pharmacist or healthcare provider for information about armodafinil tablets that is written for health professionals.

What are the ingredients in armodafinil tablets?

Active Ingredient:

Inactive Ingredients:

croscarmellose sodium, lactose monohydrate, magnesium stearate, and povidone.

For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.

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

Dispense with Medication Guide available at:

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India

Revised: 04/2023

Revised: 4/2024
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