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:

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.

• Attention-Deficit Hyperactivity Disorder (ADHD) in children 3 to 17 years of age. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
• a sleep disorder called Narcolepsy in people 6 years and older.

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 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, 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:

• have heart problems, heart disease, heart defects, or high blood pressure
• have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
• have kidney problems, including end stage renal disease (ERSD)
• have seizures or have had an abnormal brain wave test (EEG)
• have circulation problems in fingers or toes
• have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome
• are pregnant or plan to become pregnant. It is not known if dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets will harm the unborn baby. Tell your healthcare provider if you or your child become pregnant during treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets.
• are breastfeeding or plan to breastfeed. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets passes into breast milk. You or your child should not breastfeed during treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets. Talk to your healthcare provider about the best way to feed the baby during treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets.

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 changed during treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets.
Your healthcare provider will decide if 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:

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.

• Take dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets exactly as prescribed by your or your child’s healthcare provider.
• Your healthcare provider may change the dose if needed.
• The first dose of the day is usually taken when you first wake up.
• Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets can be taken with or without food.
• Your healthcare provider may sometimes stop dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets treatment for a while to check ADHD symptoms.

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?”

• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets. Your healthcare provider may stop your child’s dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets treatment if they are not growing or gaining weight as expected.
• Seizures. Your healthcare provider may stop treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets if you or your child have a seizure.
• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:

• Serotonin syndrome. This problem may happen when dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets is taken with certain other medicines and may be life-threatening. Stop taking dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets and call your healthcare provider or go to the nearest hospital emergency room right away if you or your child develop any of the following signs and symptoms of serotonin syndrome:

• New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets.

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

• stomach ache
• decreased appetite
• nervousness

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?

• Store dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets at room temperature, between 68 to 77°F (20 to 25°C).
• Protect dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets from light.
• Store dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets in a safe place, like a locked cabinet.
• Dispose of remaining, unused, or expired dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets by a medicine take back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no takeback program or DEA authorized collector is available, mix dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

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