Ofloxacin Tablets USP 400mg Technical Specification:
| Product Name: | Ofloxacin Tablets USP 400mg |
| Brand Name: | Generic |
| Strength: | 200mg, 400mg |
| Dosage Form: | Film Coated Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | Antibiotic, Antibacterial |
| Indication: | To treat certain bacterial infections in many different parts of the body |
| Storage: | Store at 20° to 25°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Ofloxacin Tablets USP 200mg
Ofloxacin Tablets USP 400mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Ofloxacin Tablets USP 400mg
Each Film Coated Tablets Contains:
Ofloxacin USP…………………………400mg
Excipients………………………………Q.S.
THERAPEUTIC INDICATIONS:
It is used in infections of urinary tract, gastrointestinal tract, female genital organ, skin & soft tissues and lungs (pneumonia).
CAUTION & WARNING:
CAUTION:
Keep medicine out of reach of children.
This drug may cause low blood sugar and mental health related side effects.
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.