Rifaximin Tablets USP 200mg Technical Specification:
| Product Name: | Rifaximin Tablets USP 200mg |
| Brand Name: | Generic |
| Strength: | 200mg, 400mg, 550mg |
| Dosage Form: | Film Coated Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 100s |
| 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 traveler’s diarrhea and irritable bowel syndrome |
| Storage: | Store at 20°C to 25°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Rifaximin Tablets USP 200mg
Rifaximin Tablets USP 400mg
Rifaximin Tablets USP 550mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Rifaximin Tablets USP 200mg
Each Film Coated Tablets Contains:
Rifaximin USP……………..200mg
Excipients……………………Q.S.
THERAPEUTIC INDICATIONS:
Rifaximin Tablet is used to treat traveler’s diarrhea that is caused by Escherichia coli bacteria, to prevent hepatic encephalopathy, which is a condition that occurs when your liver does not work normally and also used to treat irritable bowel syndrome with diarrhea.
CAUTION & WARNING:
CAUTION:
Keep 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°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
DOSAGE: As directed by the Physician.