FDA label
What is codeine used for?
The FDA-approved uses of codeine, 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: “Codeine sulfate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.”
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Codeine Sulfate, tablet
Indications and Usage, quoted from the label by Lannett Company, Inc. (ANDA203046). Cross-references to other label sections are left out.
Codeine sulfate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.
L i m i t ations of Use:
- Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including codeine sulfate tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Source: DailyMed label, set id 5819bdf7-300e-45b8-8f3a-447b53656293, version 29, effective January 16, 2026. NDC 0527-1698, one of 3 listings for this product.
Questions
What is codeine used for?
The FDA label says: “Codeine sulfate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.”
What drug class is codeine?
FDA lists codeine in the Opioid 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.