DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE- dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate capsule, extended release 
Burel Pharmaceuticals, LLC

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MEDICATION GUIDE
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES(DEX-troe-am-FET-uh-meen SACK-uh-rate, am-FET-uh-meen ass-PAR-tate, MAN-no-HIGH-drate, DEX-troe-am-FET-uh-meen SULL-fate, and am-FET-uh-meen SULL-fate), (mixed salts fo single-entity amphetamine product) extended-release capsules, CII


What is the most important information I should know about dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules?
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine
sulfate extended-release capsules may cause serious side effects, including:

Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Call your healthcare provider 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 monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules. 

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 monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
What is dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and 
amphetamine sulfate extended-release capsules?
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and children 6 years of age and older. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
It is not known if dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules are safe and effective in children under 6 years of age.

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules is a 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 monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules in a safe place to protect it from theft. Never give your dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate
extended-release capsules to anyone else because it may cause death or harm them. Selling or giving away dextroamphetamine saccharate,
amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules may harm others
and is against the law.

Do not take dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and 
amphetamine sulfate extended-release capsules if you or your child:

Before taking dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 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 monohydrate, dextroamphetamine sulfate and amphetamine 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 changed during treatment with dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules.
Your healthcare provider will decide if dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules can be taken with other medicines.

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

  •  selective serotonin reuptake inhibitors (SSRIs)
  • medicines used to treat migraine headaches
    called triptans.
  • lithium
  • tramadol
  • buspirone
  • serotonin norepinephrine reuptake inhibitors
    (SNRIs)
  • tricyclic antidepressants
  • fentanyl
  • trytophan
  • 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 monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules without talking to your healthcare provider first.
How should dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules be taken?

If you or your child take too much dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules call your healthcare provider or Poison Help Line at 1-800-222-1222 or go to the nearest hospital emergency room right away.———————————————————————————————————————————————————————————————
 What are possible side effects of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules?

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules may cause serious side effects, including:

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

Call your healthcare provider right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules.

  • agitation, hallucinations, coma, or other changes in mental status
  • problems controlling movements or muscle twitching
  • fast heartbeat
  • seizures
  • loss of coordination
  • confusion
  • dizziness
  • change in blood pressure
  • sweating or fever
  • nausea, vomiting, diarrhea
  • muscle stiffness or tightness
  • high body temperature (hyperthermia)

The most common side effects of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules in children ages 6 to 12 include:

  • loss of appetite
  • trouble sleeping
  • stomach (abdominal) pain
  • mood swings
  • vomiting
  • nervousness
  • nausea
  • fever

The most common side effects of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules in adolescents ages 13 to 17 include:

  • loss of appetite
  • trouble sleeping
  • stomach (abdominal pain)
  • weight loss
  • nervousness

The most common side effects of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules in adults include:

  • dry mouth
  • loss of appetite
  • trouble sleeping
  • headache
  • weight loss
  • nausea
  • anxiety
  • agitation
  • dizziness
  • fast heartbeat
  • diarrhea
  • weakness
  • urinary tract infections (UTIs)


These are not all possible side effects of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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How should I store dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules?

Keep dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules and all medicines out of the reach of children.
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General information about the safe and effective use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules for a condition for which it was not prescribed. Do not give dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 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 monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules that is written for healthcare professionals.
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 What are the ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules?

Active Ingredient: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate, and amphetamine aspartate monohydrate

Inactive Ingredients: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. 
The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. 
The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40.
The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6.
The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3.
The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6.
The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40.

The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac.

Manufactured for: Burel Pharmaceuticals, LLC
Mason, OH 45040 USA
For more information call 1-888-852-6657 

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

PI0550
Rev. 05/2024

Revised: 5/2024
Burel Pharmaceuticals, LLC