AMPHETAMINE SULFATE - amphetamine sulfate tablet 
Aurolife Pharma, LLC

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MEDICATION GUIDE

Amphetamine Sulfate Tablets (am-FET-uh-meen SULL-fate) , USP
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, USP?
Amphetamine Sulfate Tablets are 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 may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. Amphetamine Sulfate Tablets should be used as part of a total treatment program for ADHD that may include counseling or other therapies.


Amphetamine Sulfate Tablets are federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep Amphetamine Sulfate Tablets are in a safe place to protect it from theft. Never give your Amphetamine Sulfate Tablets are to anyone else, because it may cause death or harm them. Selling or giving away Amphetamine Sulfate Tablets are 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 affects 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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088.

How should I store Amphetamine Sulfate Tablets?

Store Amphetamine Sulfate Tablets at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Amphetamine Sulfate Tablets and all medicines out of the reach of children.

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, Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

What are the ingredients in Amphetamine Sulfate Tablets?

Active Ingredient: amphetamine sulfate

Inactive Ingredients: Crospovidone, Stearic Acid, Silicified Microcrystalline cellulose, FD & C Blue# 1.


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


Dispense with Medication Guide available atwww.aurobindousa.com/medication-guides


Distributed by:
Aurobindo Pharma USA, Inc.

279 Princeton-Hightstown Road

East Windsor, NJ 08520


Revised:09/2019

Revised: 1/2022
Aurolife Pharma, LLC