FDA label
What is Cotempla XR-ODT used for?
Cotempla XR-ODT 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: “COTEMPLA XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.”
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Cotempla XR-ODT, tablet, orally disintegrating
Indications and Usage, quoted from the label by Neos Therapeutics Brands, LLC (NDA205489). Cross-references to other label sections are left out.
COTEMPLA XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.
Limitations of Use
The use of COTEMPLA XR-ODT 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 33f70f58-c871-42c8-8adb-345caeafefcd, version 16, effective March 2, 2026. NDC 70165-100, one of 3 listings for this product.
Questions
What is Cotempla XR-ODT used for?
The FDA label says: “COTEMPLA XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.”
What drug class is Cotempla XR-ODT?
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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