| Product Name: | Celecoxib Capsules |
| Brand Name: | Generic |
| Strength: | 50mg,100mg,200mg |
| Dosage Form: | Capsules (Hard gelatin) |
| 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: | Celecoxib is used to relieve pain, tenderness, swelling and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), and ankylosing spondylitis (arthritis that mainly affects the spine). |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Celecoxib Capsules 50mg
- Celecoxib Capsules 100mg
- Celecoxib Capsules 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Celecoxib Capsules 50mg
Each hard gelatin capsule contains:
Celecoxib BP……………………….50mg
Excipients……………………………q.s.
Approved Colours are used in capsule shells. - Celecoxib Capsules 100mg
Each hard gelatin capsule contains:
Celecoxib BP……………………….100mg
Excipients……………………………q.s.
Approved Colours are used in capsule shells. - Celecoxib Capsules 200mg
Each hard gelatin capsule contains:
Celecoxib BP……………………….200mg
Excipients……………………………q.s.
Approved Colours are used in capsule shells.
THERAPEUTIC INDICATIONS:
Celecoxib is used to relieve pain, tenderness, swelling and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), and ankylosing spondylitis (arthritis that mainly affects the spine).
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.