GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Metaxalone Tablets USP 400mg
B. Metaxalone Tablets USP 800mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Metaxalone Tablets USP 400mg
Each uncoated tablet contains:
Metaxalone USP…………………….400mg
Excipients……………………………...q. s
Colour: Ferric Oxide Yellow USP-NF

B) Metaxalone Tablets USP 800mg
Each uncoated tablet contains:
Metaxalone USP…………………….800mg
Excipients……………………………...q. s
Colour: Indigo Carmine Lake

THERAPEUTIC INDICATIONS:

Metaxalone, a muscle relaxant, is used with rest, physical therapy, and other measures to relax muscles and relieve pain and discomfort caused by strains, sprains, and other muscle injuries.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Tablets to be swallowed as a whole, and not to be chewed or crushed.

SCHEDULE H PRESCRIPTION DRUG-CAUTION: Not to be sold by retail without the prescription of registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at temperature not exceeding 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by physician.

Metaxalone Tablets USP 800mg Technical specification :

Product Name: Metaxalone Tablets USP
Brand Name: Generic name
Strength: 400mg, 800mg
Dosage Form: Tablet
Route of Administration: Via Oral Route
Packing: 10 strips of 10 Capsules each
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Regulatory Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Musculoskeletal Diseases
Indication: Metaxalone, a muscle relaxant, is used with rest, physical therapy, and other measures to relax muscles and relieve pain and discomfort caused by strains, sprains, and other muscle injuries.
Storage: Store at temperature not exceeding 30℃. Store in cool, dry & dark place Protect from Light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Metaxalone Tablets USP 400mg
  • Metaxalone Tablets USP 800mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Metaxalone Tablets USP 400mg
    Each Uncoated tablet contains:
    Metaxalone………………………….400mg
    Excipients………………………………q. s
    Colour: Ferric Oxide Yellow USP-NF
  • Metaxalone USP Tablets 800mg
    Each Uncoated tablet contains:
    Metaxalone………………………….800mg
    Excipients………………………………q. s
    Colour: Indigo Carmine Lake

THERAPEUTIC INDICATIONS:

  • Metaxalone, a muscle relaxant, is used with rest, physical therapy, and other measures to relax muscles and relieve pain and discomfort caused by strains, sprains, and other muscle injuries.

CAUTION & SCHEDULE:

  • CAUTION: Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    Tablets to be swallowed as a whole, and not to be chewed or crushed.
  • SCHEDULE H PRESCRIPTION DRUG-CAUTION: Not to be sold by retail without the prescription of registered Medical Practitioner.

STORAGE & DOSAGE:

  • Storage:Store at temperature not exceeding 30℃. Store in cool, dry & dark place.Protect from Light & moisture.
  • Dosage: As directed by physician.