| Product Name: | Metaxalone and Diclofenac Potassium tablets |
| Brand Name: | Generic |
| Strength: | 400mg+50mg |
| Dosage Form: | Tablet (uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10 strips of 10 Tablets each |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Gastroenterological |
| Indication: | Diclofenac+ Metaxalone is used in pain due to muscle spasm. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) which works by blocking the release of certain chemical messengers that cause pain and inflammation (redness and swelling). Metaxalone is a muscle relaxant. |
| Storage: | Store at temperature not exceeding 30℃. Store in cool, dry & dark place Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Metaxalone and Diclofenac PotassiumTablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Metaxalone and Diclofenac PotassiumTablets
Each uncoated Tablet contains:
Nortriptyline Hydrochloride IP
Metaxalone USP………………………………..400mg
Diclofenac Potassium BP……………………50mg
Excipients…………………………………………..q.s
Colour: Ferric Oxide Yellow USP-NF
THERAPEUTIC INDICATIONS:
Diclofenac+ Metaxalone is used in pain due to muscle spasm. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) which works by blocking the release of certain chemical messengers that cause pain and inflammation (redness and swelling). Metaxalone is a muscle relaxant.
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.
Not for veterinary use.
SCHEDULE H PRESCRIPTION DRUG- CAUTION: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at temperature not exceeding 30℃. Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by physician.