Gemfibrozil Tablets USP 600mg
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Gemfibrozil Tablets USP 600mg Technical Specification:

Product Name: Gemfibrozil Tablets USP 600mg
Brand Name:Generics
Strength:(300mg), (600mg), (900mg)
Dosage Form:Tablets (Film-coated)
Route of Administration:Via oral Route
Packing:30s, 90s, 100s, 500s
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: Gemfibrozil is used together with a proper diet to treat high cholesterol and triglyceride (fat) levels in the blood. This may help prevent the development of pancreatitis (inflammation or swelling of the pancreas) caused by high levels of triglycerides 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:

  • Gemfibrozil Tablets USP 300mg
    Each Film-coated tablet contains:
    Gemfibrozil USP …………….300mg
    Excipients…………………………….… q.s.
    Colour: Red Oxide iron
  • Gemfibrozil Tablets USP 600mg
    Each Film-coated tablet contains:
    Gemfibrozil USP …………….600mg
    Excipients…………………………….… q.s.
    Colour: Sunset Yellow
  • Gemfibrozil Tablets USP 900mg
    Each Film-coated tablet contains:
    Gemfibrozil USP …………….900mg
    Excipients…………………………….… q.s.
    Colour: Quinoline Yellow

THERAPEUTIC INDICATIONS:

Gemfibrozil is used together with a proper diet to treat high cholesterol and triglyceride (fat) levels in the blood. This may help prevent the development of pancreatitis (inflammation or swelling of the pancreas) caused by high levels of triglycerides 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 Registered Medical Practitioner 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. Gemfibrozil Tablets USP 300mg
B. Gemfibrozil Tablets USP 600mg
C. Gemfibrozil Tablets USP 900mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Gemfibrozil Tablets USP 300mg
Each Film-coated tablet contains:
Gemfibrozil USP …………….300mg
Excipients…………………………….… q.s.
Colour: Red Oxide iron

b) Gemfibrozil Tablets USP 600mg
Each Film-coated tablet contains:
Gemfibrozil USP …………….600mg
Excipients…………………………….… q.s.
Colour: Sunset yellow

c) Gemfibrozil Tablets USP 900mg
Each Film-coated tablet contains:
Gemfibrozil USP …………….900mg
Excipients…………………………….… q.s.
Colour: Quinoline Yellow

THERAPEUTIC INDICATIONS:

Gemfibrozil is used together with a proper diet to treat high cholesterol and triglyceride (fat) levels in the blood. This may help prevent the development of pancreatitis (inflammation or swelling of the pancreas) caused by high levels of triglycerides 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 Registered Medical Practitioner 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.