Metformin hydrochloride ER Tablets USP 500mg Technical Specification:

Product Name:                                  Metformin hydrochloride ER Tablets USP 500mg
Brand Name:Generics
Strength:500mg, 750mg, 1000mg
Dosage Form:Tablets (Un-coated)
Route of Administration:Via oral Route
Packing:28s,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:Antidiabetic, Diabetology
Indication: Metformin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes.
Storage:Store at controlled room temperature 20-25°C. Store all of your medicines in a cool, dry place.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Metformin hydrochloride ER 500mg tablets  

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Metformin hydrochloride ER 500mg tablets
    Each Uncoated tablet contains:
    Metformin hydrochloride USP……………….500mg
    Excipients………………………………………. q.s.
    Colours: Quinoline Yellow

THERAPEUTIC INDICATIONS:

Metformin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems.

CAUTION & WARNING:

CAUTION:  Read enclosed leaflet before use.
Keep medicine 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 controlled room temperature 20-25°C. Store all of your medicines in a cool, dry place.
Dosage:  As directed by the Physician.

Attach dispensing label as per end county.

 

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Metformin hydrochloride ER 500mg tablets
B. Metformin hydrochloride ER 750mg tablets
C. Metformin hydrochloride ER 1000mg tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Metformin hydrochloride ER 500mg tablets
Each Uncoated tablet contains:
Metformin hydrochloride USP……………….500mg
Excipients………………………………………. q.s.
Colours: Titanium dioxide USP


B. Metformin hydrochloride ER 750mg tablets
Each Uncoated tablet contains:
Metformin hydrochloride USP……………….750mg
Excipients………………………………………. q.s.
Colours: Titanium dioxide Red

C. Metformin hydrochloride ER 1000mg tablets
Each Uncoated tablet contains:
Metformin hydrochloride USP……………….1000mg
Excipients………………………………………. q.s.
Colours: Quinoline Yellow

THERAPEUTIC INDICATIONS:

Metformin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE 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 controlled room temperature 20-25°C. Store all of your medicines in a cool, dry place.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.