DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE- dextroamphetamine sulfate capsule, extended release 
Amneal Pharmaceuticals of New York LLC

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MEDICATION GUIDE

Dextroamphetamine Sulfate (dex” troe am fet’ a meen sul’ fate) Extended-Release Capsules, CII

Read the Medication Guide that comes with dextroamphetamine sulfate extended-release capsules before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s treatment with dextroamphetamine sulfate extended-release capsules.

What is the most important information I should know about dextroamphetamine sulfate extended-release capsules?

The following have been reported with use of dextroamphetamine sulfate extended-release capsules and other stimulant medicines.

1. Heart-related problems:

  • Sudden death in patients who have heart problems or heart defects
  • Stroke and heart attack in adults
  • Increased blood pressure and heart rate

Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting dextroamphetamine sulfate extended-release capsules.

Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with dextroamphetamine sulfate extended-release capsules.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking dextroamphetamine sulfate extended-release capsules.

2. Mental (Psychiatric) problems:

All Patients

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

Children and Teenagers

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child has any new or worsening mental symptoms or problems while taking dextroamphetamine sulfate extended-release capsules, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

3. Circulation problems in fingers and toes
[Peripheral vasculopathy, including Raynaud’s phenomenon]:

  • fingers or toes may feel numb, cool, painful
  • fingers or toes may change color from pale, to blue, to red

Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.


Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking dextroamphetamine sulfate.

What are dextroamphetamine sulfate extended-release capsules?

Dextroamphetamine sulfate extended-release capsules are a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).

Dextroamphetamine sulfate extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Dextroamphetamine sulfate extended-release capsules should be used as a part of a total treatment program for ADHD that may include counselling or other therapies.

Dextroamphetamine sulfate extended-release capsules are also used in the treatment of a sleep disorder called narcolepsy.

Dextroamphetamine sulfate is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep dextroamphetamine sulfate extended-release capsules in a safe place to prevent misuse and abuse. Selling or giving away dextroamphetamine sulfate extended-release capsules may harm others and is against the law.


Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take dextroamphetamine sulfate extended-release capsules?

Dextroamphetamine sulfate extended-release capsules should not be taken if you or your child:

Dextroamphetamine sulfate extended-release capsules are not recommended for use in children younger than 6 years old.

Dextroamphetamine sulfate extended-release capsules may not be right for you or your child. Before starting dextroamphetamine sulfate extended-release capsules tell your or your child’s doctor about all health conditions (or a family history of) including:

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can dextroamphetamine sulfate extended-release capsules be taken with other medicines?


Tell your doctor about all of the medicines that you or your child takes including prescription and non-prescription medicines, vitamins, and herbal supplements.


Dextroamphetamine sulfate extended-release capsules and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking dextroamphetamine sulfate extended-release capsules.

Your doctor will decide whether dextroamphetamine sulfate extended-release capsules can be taken with other medicines.

Especially tell your doctor if you or your child takes:

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking dextroamphetamine sulfate extended-release capsules without talking to your doctor first.

How should dextroamphetamine sulfate extended-release capsules be taken?

What are possible side effects of dextroamphetamine sulfate extended-release capsules?

See “What is the most important information I should know about dextroamphetamine sulfate extended-release capsules?” for information on reported heart and mental problems.

Other serious side effects include:

Common side effects include:

Dextroamphetamine sulfate extended-release capsules may affect your or your child’s ability to drive or do other dangerous activities.

Talk to your doctor if you or your child has side effects that are bothersome or do not go away. This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information. 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 dextroamphetamine sulfate extended-release capsules?

General information about dextroamphetamine sulfate extended-release capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use dextroamphetamine sulfate extended-release capsules for a condition for which it was not prescribed. Do not give dextroamphetamine sulfate extended-release capsules to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about dextroamphetamine sulfate extended-release capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about dextroamphetamine sulfate extended-release capsules that was written for healthcare professionals. For more information about dextroamphetamine sulfate extended-release capsules, please contact Amneal Pharmaceuticals at 1-877-835-5472 or visit www.amneal.com.

What are the ingredients in dextroamphetamine sulfate extended-release capsules?

Active Ingredient:
Dextroamphetamine sulfate

Inactive Ingredients:
Cetyl alcohol, D&C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres and trace amounts of other inactive ingredients.

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

Manufactured by:
Catalent Pharma Solutions

Winchester, KY 40391

Distributed by:
Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 03-2019-00

For additional copies of the printed medication guide, please visit www.amneal.com or contact us at 1-877-835-5472.

Revised: 6/2019
Amneal Pharmaceuticals of New York LLC