| Product Name: | Nitrofurantoin Sustained-Release Tablets |
| Brand Name: | Generic |
| Strength: | 50mg, 100mg |
| Dosage Form: | Sustained Release Tablets (Film-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: | Antibiotic |
| Indication: | Nitrofurantoin is used to treat urinary tract infections. Nitrofurantoin is in a class of medications called antibiotics. It works by killing bacteria that cause infection. Antibiotics such as nitrofurantoin will not work for colds, flu, or other viral infections. |
| Storage: | Store at 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Nitrofurantoin Sustained Release Tablets 50mg
- Nitrofurantoin Sustained Release Tablets 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Nitrofurantoin Sustained Release Tablets 50mg
Each Film-coated, Sustained Release Tablet contains:
Nitrofurantoin ………………………………………50mg
Excipients……………………………………………….q.s.
Color: Ferric Oxide of Red USP - Nitrofurantoin Sustained Release Tablets 100mg
Each Film-coated, Sustained Release Tablet contains:
Nitrofurantoin ………………………………………100mg
Excipients……………………………………………….q.s.
Color: Ferric Oxide of Red USP
THERAPEUTIC INDICATIONS:
Nitrofurantoin is used to treat urinary tract infections. Nitrofurantoin is in a class of medications called antibiotics. It works by killing bacteria that cause infection. Antibiotics such as nitrofurantoin will not work for colds, flu, or other viral infections.
CAUTION & WARNING:
CAUTION:
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
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).
Dosage: As directed by the Physician.