FDA label

What is metaxalone used for?

The FDA-approved uses of metaxalone, 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: “Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older.”

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Metaxalone, tablet

Indications and Usage, quoted from the label by Amneal Pharmaceuticals of New York LLC (ANDA040486). Cross-references to other label sections are left out.

Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older.

Source: DailyMed label, set id de3448df-4ca1-44ec-bad1-486549cddf64, version 9, effective August 30, 2024. NDC 0115-1745, one of 62 listings for this product.

Questions

What is metaxalone used for?

The FDA label says: “Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older.”

What drug class is metaxalone?

FDA lists metaxalone in the Muscle Relaxant 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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