FDA label
What is varenicline used for?
The FDA-approved uses of varenicline, 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: “Varenicline tablets are indicated for use as an aid to smoking cessation treatment.”
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Varenicline, tablet, film coated
Indications and Usage, quoted from the label by Apotex Corp (ANDA201962). Cross-references to other label sections are left out.
Varenicline tablets are indicated for use as an aid to smoking cessation treatment.
Source: DailyMed label, set id 78d1857f-8708-5410-792f-4a3e5e7971a5, version 6, effective September 18, 2026. NDC 60505-3613, one of 57 listings for this product.
Questions
What is varenicline used for?
The FDA label says: “Varenicline tablets are indicated for use as an aid to smoking cessation treatment.”
What drug class is varenicline?
FDA lists varenicline in the Partial Cholinergic Nicotinic Agonist and Cholinergic Receptor Agonist 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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