Choline Fenofibrate DR Capsules 45mg
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Choline Fenofibrate DR Capsules 45mg Technical Specification:

Product Name: Choline Fenofibrate DR Capsules 45mg
Brand Name: Generics
Strength: (45mg), (135mg)
Dosage Form: Capsule (Hard-Gelatine)
Route of Administration: Via oral Route
Packing: 90s, 100s, 500s, 1000s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
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: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Choline Fenofibrate DR Capsules 45mg
    Each delayed-release capsule contains:
    Choline Fenofibrate
    Equivalent to Fenofibrate acid…………45mg
    Excipients……………………………. q.s.
    Colours: Ferric Oxide Yellow USP-NF
  • Choline Fenofibrate DR Capsules 135mg|
    Each delayed-release capsule contains:|
    Choline Fenofibrate
    Equivalent to Fenofibrate acid…………135mg
    Excipients……………………………. q.s.
    Colours: 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

Warning: To be sold by retail on the prescription of a Cardiologist only.

STORAGE & DOSAGE:

Storage:  Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.

Dosage:  As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Choline Fenofibrate DR Capsules 45mg
B. Choline Fenofibrate DR Capsules 135mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Choline Fenofibrate DR Capsules 45mg
Each delayed release capsule contains:
Choline Fenofibrate
Equivalent to Fenofibrate acid…………45mg
Excipients……………………………. q.s.
Colours: Ferric Oxide Yellow USP-NF

b) Choline Fenofibrate DR Capsules 135mg
Each delayed release capsule contains:
Choline Fenofibrate
Equivalent to Fenofibrate acid…………135mg
Excipients……………………………. q.s.
Colours: 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 enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

WARNING: To be sold by retail on the prescription of a Cardiologist only.

STORAGE & DOSAGE:

Storage: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.

Dosage: As directed by the Physician.