| Product Name: | Diclofenac Sodium + Paracetamol + Chlorzoxazone Tablets |
| Brand Name: | Generic name |
| Strength: | 325mg+50mg+250mg, 325mg+50mg+500mg |
| 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: | Analgesic & Anti-inflammatory |
| Indication: | This is a combination of a muscle relaxant (Chlorzoxazone) and two pain relieving medicines (Diclofenac and Paracetamol). The muscle relaxant works on the centres in the brain and spinal cord to relieve muscle stiffness or spasms, thereby improving the movement of muscles. The pain-relieving medicines work by blocking the release of certain chemical messengers in the brain that cause pain and inflammation (redness and swelling). |
| Storage: | Store at a temperature not exceeding 30℃. Store in a cool, dry & dark place Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Paracetamol, Diclofenac and Chlorzoxazone Tablets (325mg+50mg+250mg)
- Paracetamol, Diclofenac and Chlorzoxazone Tablets (325mg+50mg+500mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Paracetamol +Diclofenac Sodium+ Chlorzoxazone Tablets
Each uncoated Tablet contains:
Paracetamol IP………………………….325mg
Diclofenac Sodium IP……………..50mg
Chlorzoxazone USP…………………….500mg
Colour: Red oxide of iron
B) Paracetamol +Diclofenac Sodium + Chlorzoxazone Tablets
Each uncoated Tablet contains:
Paracetamol IP………………………….325mg
Diclofenac Sodium IP……………..50mg
Chlorzoxazone USP…………………….250mg
Colour: Red oxide of iron
THERAPEUTIC INDICATIONS:
This is a combination of a muscle relaxant (Chlorzoxazone) and two pain relieving medicines (Diclofenac and Paracetamol). The muscle relaxant works on the centres in the brain and spinal cord to relieve muscle stiffness or spasms, thereby improving the movement of muscles. The pain-relieving medicines work by blocking the release of certain chemical messengers in the brain that cause pain and inflammation (redness and swelling).
CAUTION & SCHEDULE:
CAUTION: Read the enclosed leaflet before use.
Keep medicine out of reach of children.
Tablets are to be swallowed as a whole, and not to be chewed or crushed.
WARNING: Taking more than a daily dose of Paracetamol may cause serious liver damage or allergic reactions (e.g., Swelling of face, mouth and throat, difficulty in breathing, itching or rash.)
Overdose of paracetamol may be injurious to the liver.
Not for veterinary use.
SCHEDULE H DRUG- WARNING: Not to be sold by retail without the prescription of a registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding 30℃. Store in a cool, dry & dark place. Protect from Light & moisture.
Dosage: As directed by physician.