FDA label
What is dextroamphetamine and amphetamine used for?
The FDA-approved uses of dextroamphetamine and amphetamine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (capsule, extended release) lists this use: Attention Deficit Hyperactivity Disorder.
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Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate, tablet
Indications and Usage, quoted from the label by SUNRISE PHARMACEUTICAL, INC. (ANDA209799). Cross-references to other label sections are left out.
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Amphetamine Product) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
Attention Deficit Hyperactivity Disorder (ADHD)
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Source: DailyMed label, set id ac102599-3a5b-4154-899e-6ff262be7ff7, version 10, effective August 4, 2026. NDC 11534-190, one of 87 listings for this product.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate, capsule, extended release
Indications and Usage, quoted from the label by Rhodes Pharmaceuticals LLC (ANDA210651). Cross-references to other label sections are left out.
Attention Deficit Hyperactivity Disorder
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
Limitations of Use
The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.
Source: DailyMed label, set id 690e1ef4-caf7-4c48-a4ae-d2a0ab684e82, version 8, effective May 8, 2026. NDC 42858-055, one of 32 listings for this product.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate, capsule, extended release
Indications and Usage, quoted from the label by SpecGx LLC (ANDA211546). Cross-references to other label sections are left out.
Mixed Salts of a Single-Entity Amphetamine Product Extended-Release Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older.
Limitations of Use: Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite.
Source: DailyMed label, set id e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78, version 9, effective October 13, 2026. NDC 0406-0803, one of 21 listings for this product.
Questions
What is dextroamphetamine and amphetamine used for?
The FDA label for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (capsule, extended release) lists this use: Attention Deficit Hyperactivity Disorder.
What drug class is dextroamphetamine and amphetamine?
FDA lists dextroamphetamine and amphetamine in the Central Nervous System Stimulant established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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