Metaxalone Tablets USP 400mg

Metaxalone Tablets USP 400mg Technical Specification:

Product Name:	Metaxalone Tablets USP
Brand Name:	Generic
Strength:	400mg, 800mg
Dosage Form:	Tablets (Uncoated)
Route of Administration:	Via Oral Route
Packing:	10s, 30s, 100s, 500s
Pack Insert/Leaflet:	PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:	COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:	Musculoskeletal Diseases, Analgesic
Indication:	Metaxalone is used to help relax the muscles in your body and relieve the discomfort caused by acute (short-term), painful muscle or bone conditions.
Storage:	Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

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 Red USP-NF
B) Metaxalone Tablets USP 800mg
Each uncoated tablet contains:
Metaxalone USP 800mg
Excipients q.s.
Colour: Ferric Oxide Red USP-NF

THERAPEUTIC INDICATIONS:

Metaxalone is a muscle relaxant medication used to relax muscles and relieve pain caused by strains, sprains, and other musculoskeletal conditions.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light and moisture.

Dosage: As directed by the Physician
Attach dispensing label as per end county.