GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Mecobalamin Tablets 500mcg
B) Mecobalamin Tablets 1000mcg
C) Mecobalamin Tablets 1500mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Mecobalamin Tablets 500mcg
Each uncoated tablet contains:
Methyldopa JP……………500mg
Excipients……………………q.s
Colour: Lake of Erythrosine
Appropriate overage of vitamin is added.

B) Mecobalamin Tablets 1000mcg
Each uncoated tablet contains:
Methyldopa JP…………….1000mg
Excipients………………………q.s
Colour: Quinoline yellow WS
Appropriate overage of vitamin is added.

C) Mecobalamin Tablets 1500mcg
Each uncoated tablet contains:
Methyldopa JP…………………1500mg
Excipients…………………………..q.s
Colour: Ponceau 2 R
Appropriate overage of vitamin is added.

THERAPEUTIC INDICATIONS:

METHYLCOBALAMIN belongs to the class of vitamins primarily used to treat peripheral neuropathies and megaloblastic anaemia caused by vitamin B12 deficiency. Megaloblastic anaemia is a condition in which the red blood cells are abnormally large. Peripheral neuropathy causes damage to the nerves located outside the spinal cord and brain.

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: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container. Protect from Light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.

Mecobalamin Tablets 1500mcg Technical Specification:

Product Name: Mecobalamin Tablets
Brand Name: Generic
Strength: 500mcg, 1000mcg, 1500mcg
Dosage Form: Tablets (Uncoated)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 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: Vitamins, Nutritional Supplements
Indication: Methylcobalamin is used to treat vitamin B12 deficiency.
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Mecobalamin Tablets 500mcg
B) Mecobalamin Tablets 1000mcg
C) Mecobalamin Tablets 1500mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Mecobalamin Tablets 500mcg
Each uncoated tablet contains:
Methyldopa JP……………500mg
Excipients……………………q.s
Colour: Lake of Erythrosine
Appropriate overage of vitamin is added.

B) Mecobalamin Tablets 1000mcg
Each uncoated tablet contains:
Methyldopa JP…………….1000mg
Excipients………………………q.s
Colour: Quinoline yellow WS
Appropriate overage of vitamin is added.

C) Mecobalamin Tablets 1500mcg
Each uncoated tablet contains:
Methyldopa JP…………………1500mg
Excipients…………………………..q.s
Colour: Ponceau 2 R
Appropriate overage of vitamin is added.

THERAPEUTIC INDICATIONS:

METHYLCOBALAMIN belongs to the class of vitamins primarily used to treat peripheral neuropathies and megaloblastic anaemia caused by vitamin B12 deficiency. Megaloblastic anaemia is a condition in which the red blood cells are abnormally large. Peripheral neuropathy causes damage to the nerves located outside the spinal cord and brain.

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: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container. Protect from Light and moisture.
Dosage: As directed by the Physician

Attach dispensing label as per end country.