FDA label
What is Concerta used for?
Concerta contains methylphenidate. 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: “CONCERTA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old.”
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Concerta, tablet, extended release
Indications and Usage, quoted from the label by Janssen Pharmaceuticals, Inc. (NDA021121). Cross-references to other label sections are left out.
CONCERTA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old.
Limitations of Use
The use of CONCERTA 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 1a88218c-5b18-4220-8f56-526de1a276cd, version 30, effective April 20, 2026. NDC 50458-585, one of 4 listings for this product.
Questions
What is Concerta used for?
The FDA label says: “CONCERTA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old.”
What drug class is Concerta?
FDA lists methylphenidate 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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