Choline Fenofibrate DR Tablets 135mg Technical Specification:
| Product Name: | Choline Fenofibrate DR Tablets 135mg |
| Brand Name: | Generics |
| Strength: | (45mg), (135mg) |
| Dosage Form: | Tablets (Hard-Gelatine) |
| Route of Administration: | Via oral Route |
| Packing: | 90s, 100s, 500s, 1000s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antihyperlipidemic |
| Indication: | Feno fibric acid is used along with a proper diet to help lower “bad” cholesterol and fats (such as LDL, triglycerides) and raise “good” cholesterol (HDL) in the blood. It works by increasing the natural substance (enzyme) that breaks down fats in the blood. |
| Storage: | Store below 25˚C. Protect from Light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Choline Fenofibrate DR Tablets 45mg
- Choline Fenofibrate DR Tablets 135mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Choline Fenofibrate DR Tablets 45mg
Each delayed-release tablet contains:
Choline Fenofibrate IP
Equivalent to Fenofibrate acid…………45mg
Excipients……………………………. q.s.
Colours: Ferric Oxide Yellow USP-NF & Titanium Dioxide IP
- Choline Fenofibrate DR Tablets 135mg
Each delayed-release tablet contains:
Choline Fenofibrate IP
Equivalent to Fenofibrate acid…………135mg
Excipients……………………………. q.s.
Colours: Ferric Oxide Yellow USP-NF & Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
Fenofibric acid is used along with a proper diet to help lower “bad” cholesterol and fats (such as LDL, triglycerides) and raise “good” cholesterol (HDL) in the blood. It works by increasing the natural substance (enzyme) that breaks down fats in the blood.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: To be sold by retail on the prescription of a Cardiologist only.
STORAGE & DOSAGE:
Storage: Store below 25˚C. Protect from Light and moisture.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Choline Fenofibrate DR Tablets 135mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each delayed release tablet contains:
Choline Fenofibrate IP
Equivalent to Fenofibrate acid…………45mg
Excipients……………………………. q.s.
Colours: Ferric Oxide Yellow USP-NF & Titanium Dioxide IP
b) Choline Fenofibrate DR Tablets 135mg
Each delayed release tablet contains:
Choline Fenofibrate IP
Equivalent to Fenofibrate acid…………135mg
Excipients……………………………. q.s.
Colours: Ferric Oxide Yellow USP-NF & Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: To be sold by retail on the prescription of Cardiologist only.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.

