FDA label
What is Dexedrine used for?
Dexedrine contains dextroamphetamine. The FDA-approved uses below are 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 says: “DEXEDRINE is indicated in:”
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Dexedrine, capsule, extended release
Indications and Usage, quoted from the label by Amneal Pharmaceuticals LLC (NDA017078). Cross-references to other label sections are left out.
DEXEDRINE is indicated in:
Narcolepsy
Attention Deficit Disorder with Hyperactivity
As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of the 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 2 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 6 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 6 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.
Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presences of the required number of DSM-IV characteristics.
Need for Comprehensive Treatment Program
DEXEDRINE is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms.
Limitations of Use
The use of DEXEDRINE 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 cc717b9b-22ea-4c60-a1d4-ee38a40bce78, version 15, effective September 25, 2025. NDC 64896-673, one of 3 listings for this product.
Questions
What is Dexedrine used for?
The FDA label says: “DEXEDRINE is indicated in:”
What drug class is Dexedrine?
FDA lists dextroamphetamine 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.
More on Dexedrine
- Is Dexedrine a controlled substance?Schedule II
- What is Dextroamphetamine used for?FDA label uses
- Is Dextroamphetamine a controlled substance?Schedule II
- Generic for Dexedrine SpansuleFDA Orange Book
- Generic for XelstrymFDA Orange Book
- Central Nervous System Stimulants listFDA drug class
- NDC 64896-673Dexedrine NDC record
- NDC 64896-674Dexedrine NDC record
- NDC 64896-675Dexedrine NDC record
- Schedule II drugs listDEA schedule