| Product Name: | Nystatin Tablets BP |
| Brand Name: | Generic |
| Strength: | 500,000IU |
| 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: | Anti-fungal |
| Indication: | Nystatin is an antifungal medicine. It’s used to treat or prevent infections caused by a fungus (or yeast). |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Nystatin Tablets BP 500,000IU
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Nystatin Tablets BP 500,000IU
Each Film coated tablet contains:
Nystatin BP……………….500,000IU
Excipients……………………q.s.
Colour: Ferric Oxide Red
THERAPEUTIC INDICATIONS:
Nystatin is an antifungal medicine. It makes holes in the cell membrane of the fungus and the contents leak out. This kills the fungus and treats the infection.
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].
Dispense in tight container.
Protect from light and moisture.
Dosage: As directed by the Physician.