AMPHETAMINE SULFATE- amphetamine tablet 
Amneal Pharmaceuticals NY LLC

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MEDICATION GUIDE

Amphetamine (am FET a meen) Sulfate Tablets, USP CII

Read this Medication Guide before you or your child starts taking amphetamine sulfate tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about you or your child's treatment.

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

Amphetamine Sulfate Tablets are a stimulant medicine. Some people have had the following problems when taking stimulant medicines such as amphetamine sulfate tablets:

1.     Heart-related problems:

  • sudden death in people 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 amphetamine sulfate tablets.

Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with amphetamine sulfate tablets.

Call your doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking amphetamine sulfate tablets.

2.      Mental (Psychiatric) problems including:

         In children, teenagers, and adults:

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

         In children and teenagers who have psychiatric problems, new psychotic symptoms such as:

  • hearing voices
  • seeing things that are not real
  • believing things that are not true
  • being suspicious
  • 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 have any new or worsening mental symptoms or problems while taking amphetamine sulfate tablets, especially:

  • seeing or hearing things that are not real
  • believing things that are not real
  • being 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 amphetamine sulfate tablets.

What are amphetamine sulfate tablets?

Amphetamine sulfate tablets are a federally controlled substance (CII) because they contain amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep amphetamine sulfate tablets in a safe place to protect them from theft. Never give your amphetamine sulfate tablets to anyone else, because they may cause death or harm them. Selling or giving away amphetamine sulfate tablets is against the law.

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

Who should not take amphetamine sulfate tablets?

Do not take amphetamine sulfate tablets if you or your child:

What should I tell my doctor before taking amphetamine sulfate tablets?

Before you or your child takes amphetamine sulfate tablets, tell your doctor if you or your child has or if there is a family history of:

Tell your doctor if:

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

Amphetamine sulfate tablets 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 amphetamine sulfate tablets.

Your doctor will decide whether amphetamine sulfate tablets 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 when you get a new medicine.

Do not start any new medicine while taking amphetamine sulfate tablets without talking to your doctor first.

How should I take amphetamine sulfate tablets?

What should I avoid while taking amphetamine sulfate tablets?

Do not drive, operate machinery, or do other dangerous activities until you know how amphetamine sulfate tablets affect you.

What are possible side effects of amphetamine sulfate tablets?

Amphetamine sulfate tablets may cause serious side effects, including:

See "What is the most important information I should know about amphetamine sulfate tablets?" for information on reported heart and mental problems.

Other serious side effects include:

The most common side effects of amphetamine sulfate tablets include:

Talk to your doctor if you or your child have side effects that are bothersome or do not go away.

These are not all the possible side effects of amphetamine sulfate tablets. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088.

How should I store amphetamine sulfate tablets?

General information about the safe and effective use of amphetamine sulfate tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use amphetamine sulfate tablets for a condition for which it was not prescribed. Do not give amphetamine sulfate tablets 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 amphetamine sulfate tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about amphetamine sulfate tablets that was written for healthcare professionals.

For more information about amphetamine sulfate tablets, please contact Amneal Pharmaceuticals at 1-877-835-5472 or visit www.amneal.com.

What are the ingredients in amphetamine sulfate tablets?

Active Ingredient: amphetamine sulfate, USP

Inactive Ingredients:  colloidal silicon dioxide, crospovidone, microcrystalline cellulose, stearic acid, and talc. The 10 mg tablets also contain FD&C Blue #1 aluminum lake.

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

Manufactured by:

Amneal Pharmaceuticals of New York, LLC

Brookhaven, NY 11719

Rev. 05-2018-00

Revised: 12/2020
Amneal Pharmaceuticals NY LLC