FDA label

What is morphine used for?

The FDA-approved uses of morphine, 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: “Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.”

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Morphine Sulfate, tablet, film coated, extended release

Indications and Usage, quoted from the label by Rhodes Pharmaceuticals LLC (ANDA074862). Cross-references to other label sections are left out.

Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.

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 morphine sulfate extended-release 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.
  • Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.

Source: DailyMed label, set id 19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804, version 16, effective May 4, 2026. NDC 42858-801, one of 38 listings for this product.

Morphine Sulfate, solution

Indications and Usage, quoted from the label by SpecGx LLC (ANDA202348). Cross-references to other label sections are left out.

Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant adult patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate 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 morphine sulfate 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 242c2512-1d49-486b-a9c3-6905f667799e, version 30, effective July 28, 2026. NDC 0406-8003, one of 15 listings for this product.

Questions

What is morphine used for?

The FDA label says: “Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.”

What drug class is morphine?

FDA lists morphine 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.

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