| Product Name: | Diclofenac Sodium Delayed-Release Tablets USP |
| Brand Name: | Generic |
| Strength: | (25mg), (50mg), (75mg), (100mg) |
| Dosage Form: | Tablets (enteric-coated) |
| 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: | Analgesic and Anti-inflammatory, Antirheumatic |
| Indication: | Diclofenac is indicated for use in the treatment of pain and inflammation from varying sources including inflammatory conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as well as injury-related inflammation due to surgery and physical trauma. |
| Storage: | Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Diclofenac Sodium Delayed-Release Tablets USP 25mg
- Diclofenac Sodium Delayed-Release Tablets USP 50mg
- Diclofenac Sodium Delayed-Release Tablets USP 75mg
- Diclofenac Sodium Delayed-Release Tablets USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Diclofenac Sodium Delayed-Release Tablets USP 25mg
Each enteric coated tablet contains:
Diclofenac Sodium USP…………………………………………..25mg
Excipients……………………………………………………………….q.s.
Color: Sunset yellow FCF - Diclofenac Sodium Delayed-Release Tablets USP 50mg
Each enteric coated tablet contains:
Diclofenac Sodium USP…………………………………………..50mg
Excipients……………………………………………………………….q.s.
Color: Tartrazine yellow - Diclofenac Sodium Delayed-Release Tablets USP 75mg
Each enteric coated tablet contains:
Diclofenac Sodium USP…………………………………………..75mg
Excipients……………………………………………………………….q.s.
Color: Red oxide of iron - Diclofenac Sodium Delayed-Release Tablets USP 100mg
Each enteric coated tablet contains:
Diclofenac Sodium USP…………………………………………..100mg
Excipients……………………………………………………………….q.s.
Color: Red oxide of iron
THERAPEUTIC INDICATIONS:
Diclofenac is indicated for use in the treatment of pain and inflammation from varying sources including inflammatory conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as well as injury-related inflammation due to surgery and physical trauma.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container as defines in the USP using a child-resistant closure.
Keep container tightly closed.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.