Ursodeoxycholic Acid Tablets IP Technical Specification:
| Product Name: | Ursodeoxycholic Acid Tablets IP |
| Brand Name: | Generic |
| Strength: | 150mg,300mg,450mg, 500mg,600mg |
| Dosage Form: | Tablets (film-coated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s,30s,100s,150s,225s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Dissolve primary biliary cirrhosis, Gallbladder stones |
| Indication: | Ursodeoxycholic Acid is a hepatoprotective medication. It works by reducing the amount of cholesterol in the blood and helps dissolve gallbladder stones that are composed mainly of cholesterol. |
| Storage: | Store at a room temperature. Protect from light & Moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Ursodeoxycholic Acid Tablets IP 150mg
Ursodeoxycholic Acid Tablets IP 300mg
Ursodeoxycholic Acid Tablets IP 450mg
Ursodeoxycholic Acid Tablets IP 500mg
Ursodeoxycholic Acid Tablets IP 600mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Ursodeoxycholic Acid IP ………….150mg
Excipients…….…. q. s.
Color: Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
Ursodeoxycholic Acid is a hepatoprotective medication. It works by reducing the amount of cholesterol in the blood and helps dissolve gallbladder stones that are composed mainly of cholesterol.
CAUTION & SCHEDULE:
Keep the medicine out of reach of children.
Tablet should be swallowed whole not to be chewed or crushed
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a registered medical practitioner Only.
STORAGE & DOSAGE:
Storage: Store below 30°C. Protect from Light and moisture.
Dosage: As directed by the Physician.