What Is Acetaminophen and Codeine Used For?

The FDA label says: “Acetaminophen and codeine phosphate 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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Acetaminophen and Codeine Phosphate, tablet

Indications and Usage, quoted from the label by SpecGx LLC (ANDA040419). Cross-references to other label sections are left out.

Acetaminophen and codeine phosphate 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.
Limitations 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 (see WARNINGS ), reserve opioid analgesics, including acetaminophen and codeine phosphate 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 eadc80fa-13c3-471a-a22f-6fe7e1ab290f, version 51, effective June 12, 2026. NDC 0406-0483, one of 72 listings for this product.

Acetaminophen and Codeine Phosphate, solution

Indications and Usage, quoted from the label by PAI Holdings, LLC dba PAI Pharma (ANDA087508). Cross-references to other label sections are left out.

Acetaminophen and codeine phosphate oral solution is indicated for the management of mild to moderate pain where treatment with an opioid is appropriate and for which alternative treatments are inadequate.
Limitations 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 acetaminophen and codeine phosphate oral solution, 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 95ac6875-6b14-4cde-8efb-80704e39b8d8, version 32, effective August 6, 2026. NDC 0121-0504, one of 3 listings for this product.

Questions

What is acetaminophen and codeine used for?

The FDA label says: “Acetaminophen and codeine phosphate 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 acetaminophen and codeine?

FDA lists acetaminophen and 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.