DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate tablet 
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MEDICATION GUIDE

Dextroamphetamine Saccharate
Amphetamine Aspartate
Dextroamphetamine Sulfate
Amphetamine Sulfate Tablets
(Mixed Salts of a Single Entity Amphetamine Product)
(dex” troe am fet' a meen sac cha rate, am fet' a meen a spar' tate, dex” troe am fet' a meen sul' fate, am fet' a meen sul' fate)

Rx only

CII

Read the Medication Guide that comes with Mixed Salts of a Single Entity Amphetamine Product 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 Mixed Salts of a Single Entity Amphetamine Product.

What is the most important information I should know about Mixed Salts of a Single Entity Amphetamine Product?

The following have been reported with use of Mixed Salts of a Single Entity Amphetamine Product 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 have 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 Mixed Salts of a Single Entity Amphetamine Product.

Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Mixed Salts of a Single Entity Amphetamine Product.

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 Mixed Salts of a Single Entity Amphetamine Product.

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 have any new or worsening mental symptoms or problems while taking Mixed Salts of a Single Entity Amphetamine Product, 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, and/or 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 the 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 Mixed Salts of a Single Entity Amphetamine Product. 

What are Mixed Salts of a Single Entity Amphetamine Product?

Mixed Salts of a Single Entity Amphetamine Product are a central nervous system stimulant prescription medicine. They are used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Mixed Salts of a Single Entity Amphetamine Product may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Mixed Salts of a Single Entity Amphetamine Product should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Mixed Salts of a Single Entity Amphetamine Product are also used in the treatment of a sleep disorder called narcolepsy.

Mixed Salts of a Single Entity Amphetamine Product are a federally controlled substance (CII) because they can be abused or lead to dependence. Keep Mixed Salts of a Single Entity Amphetamine Product in a safe place to prevent misuse and abuse. Selling or giving away Mixed Salts of a Single Entity Amphetamine Product 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 Mixed Salts of a Single Entity Amphetamine Product?

Mixed Salts of a Single Entity Amphetamine Product should not be taken if you or your child:

Mixed Salts of a Single Entity Amphetamine Product are not recommended for use in children less than 3 years old.

Mixed Salts of a Single Entity Amphetamine Product may not be right for you or your child. Before starting Mixed Salts of a Single Entity Amphetamine Product 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 are pregnant, planning to become pregnant, or breastfeeding.

Can Mixed Salts of a Single Entity Amphetamine Product be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Mixed Salts of a Single Entity Amphetamine Product 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 Mixed Salts of a Single Entity Amphetamine Product.

Your doctor will decide whether Mixed Salts of a Single Entity Amphetamine Product can be taken with other medicines.

Especially tell your doctor if you or your child take:

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

Do not start any new medicine while taking Mixed Salts of a Single Entity Amphetamine Product without talking to your doctor first.

How should Mixed Salts of a Single Entity Amphetamine Product be taken?

What are possible side effects of Mixed Salts of a Single Entity Amphetamine Product?

See “What is the most important information I should know about Mixed Salts of a Single Entity Amphetamine Product?” for information on reported heart and mental problems.

Other serious side effects include:

Common side effects include:

Mixed Salts of a Single Entity Amphetamine Product may affect your or your child’s ability to drive or do other dangerous activities.

Talk to your doctor if you or your child have 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 Mixed Salts of a Single Entity Amphetamine Product?

General information about Mixed Salts of a Single Entity Amphetamine Product

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Mixed Salts of a Single Entity Amphetamine Product for a condition for which they were not prescribed. Do not give Mixed Salts of a Single Entity Amphetamine Product 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 Mixed Salts of a Single Entity Amphetamine Product. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Mixed Salts of a Single Entity Amphetamine Product that was written for healthcare professionals, or you can visit www.Mallinckrodt.com or call 1-800-778-7898.

What are the ingredients in Mixed Salts of a Single Entity Amphetamine Product?

Active Ingredients: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate USP and amphetamine sulfate USP

Inactive Ingredients: microcrystalline cellulose, silicon dioxide, povidone and stearic acid

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

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company.

© 2017 Mallinckrodt.

SpecGx LLC
Webster Groves, MO 63119 USA

L20D11

Rev 08/2017    

Revised: 2/2020
SpecGx LLC