DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE - dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablet 
Elite Laboratories, Inc.

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MEDICATION GUIDE

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets CII 
(DEX-troe-am-FET-uh-meen SACK-uh-rate, am-FET-uh-meen ass-PAR-tate, DEX-troe-am-FET-uh-meen SULL-fate, and am-FET-uh-meen SULL-fate)


 What is the most important information I should know about dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets?


Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets may cause serious side effects, including:
  • Abuse, misuse, and addiction. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets or when it is used in ways that are not approved, such as snorting or injection.     
    • Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with           dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets and will monitor you or your child during treatment. 
    • Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets may lead to     physical dependence after prolonged use, even if taken as directed by your healthcare provider. 
    • Do not give dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets to   anyone else. See “What is dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate   tablets?” for more information.
    • Keep dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets in a safe   place and properly dispose of any unused medicine. See “How should I store dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets?” for more information. 
    • Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
    • Risks for people with serious heart disease: Sudden death has happened in people who have heart defects or other serious heart disease.
Your healthcare provider should check you or your child carefully for heart problems before starting treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.

Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets.

  • Increased blood pressure and heart rate                                                                                                                                                                                                                                                            Your healthcare provider should check you or your child's blood pressure and heart rate regularly during treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets.                                                                                                                                                                                                                                                                                                                                                                                                                   
  • Mental (psychiatric) problems, including:
  •     new or worse behavior and thought problems
  •     new or worse bipolar illness
  •     new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms
Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.



What is dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets?

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is a central nervous system (CNS) stimulant prescription medicine used for the treatment of: 

It is not known if dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is safe and effective in children with ADHD under 3 years of age.

It is not known if dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is safe and effective in children with Narcolepsy under 6 years of age.


Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets isa federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets in a safe place to protect it from theft. Never give your dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets to anyone else because it may cause death or harm them. Selling or giving away dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets may harm others, and is against the law.


Do not take dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets if you or your child: 

Before taking dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets tell your healthcare provider about all of your or your child’s medical conditions including if you or your child: 

Tell your healthcare provider about all of the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and 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 during treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets.

Your healthcare provider will decide whether dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets can be taken with other medicines.

Especially tell your healthcare provider if you or your child take:

• selective serotonin reuptake inhibitors (SSRIs)• serotonin norepinephrine reuptake inhibitors(SNRIs)
• medicines used to treat migraine headaches called triptans• tricyclic antidepressants
• lithium• fentanyl
• tramadol• tryptophan
• buspirone• St. John’s Wort

Know the medicines that you or your child take. Keep a list of your or your child's medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine.

Do not start any new medicine during treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets without talking to your healthcare provider first.

How should dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets be taken?

If you or your child take too much dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, call your healthcare provider or Poison Help line at 1-800-222-1222or go to the nearest hospital emergency room right away.

What should I avoid while taking dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets?

Do not drive, operate heavy machinery, or do other potentially dangerous activities until you know how dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets affects you.

What are possible side effects of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets?
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets may cause serious side effects, including:

See “What is the most important information I should know about dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets?” 

Tell your healthcare provider if you have or your child has any numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes. 
Call your healthcare provider right away if you have or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets.

  • agitation, hallucinations, coma
  • fast heartbeat
  • flushing
  • seizures
  • loss of coordination
  • muscle stiffness or tightness
  • confusion
  • dizziness
  • changes in blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • high body temperature (hypothermia)

The most common side effects of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets?

Keep dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets and all medicines out of the reach of children.

General information about the safe and effective use of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets for a condition for which it was not prescribed. Do not give dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets to other people, even if they have the same condition. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets that is written for healthcare professionals. 

What are the ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets?

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

Inactive Ingredients: compressible sugar, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium saccharin, and pregelatinized starch.

Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 5 mg, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake.

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.


Distributed by:

Elite Laboratories, Inc.,

Northvale, NJ 07647


For more information about dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, please contact Elite Laboratories, Inc at 888-852-6657.


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This Medication Guide has been approved by the U.S. Food and Drug Administration                                      Revised: 10/23                                                                                                     

Revised: 12/2019
Elite Laboratories, Inc.