Esomeprazole Tablets IP 20mg Technical Specification:
| Product Name: | Esomeprazole Tablets IP 20mg |
| Brand Name: | ESOTAJ |
| Strength: | (20mg), (40mg) |
| Dosage Form: | Tablets (Enteric coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-Ulcer, Gastroenterological |
| Indication: | Esomeprazole is a proton pump inhibitor (PPI). It works by reducing the amount of acid in the stomach which helps in relief of acid-related indigestion and heartburn. |
| Storage: | Store below 30°C. Protect from Light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Esomeprazole Tablets IP 20mg
- Esomeprazole Tablets IP 40mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Esomeprazole Tablets IP 20mg
Each enteric-coated tablet contains:
Esomeprazole Magnesium Trihydrate IP
Equivalent to Esomeprazole………….20mg
Excipients………………………………………q.s.
Colours: Ferric oxide (Red)USP-NF, Titanium Dioxide IP
- Esomeprazole Tablets IP 40mg
Each enteric-coated tablet contains:
Esomeprazole Magnesium Trihydrate IP
Equivalent to Esomeprazole………….40mg
Excipients………………………………………q.s.
Colours: Red oxide of iron
THERAPEUTIC INDICATIONS:
Esomeprazole is a proton pump inhibitor (PPI). It works by reducing the amount of acid in the stomach which helps in relief of acid-related indigestion and heartburn.
CAUTION & SCHEDULE:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
STORAGE & DOSAGE:
Storage: Store below 30°C. Protect from Light and moisture.
Dosage: As directed by the Physician
GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Esomeprazole Tablets IP 40mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each enteric coated tablet contains:
Esomeprazole Magnesium Trihydrate IP
Equivalent to Esomeprazole………….20mg
Excipients………………………………………q.s.
Colours: Ferric oxide (Red)USP-NF, Titanium Dioxide IP
B) Esomeprazole Tablets IP 40mg
Each enteric coated tablet contains:
Esomeprazole Magnesium Trihydrate IP
Equivalent to Esomeprazole………….40mg
Excipients………………………………………q.s.
Colours: Red oxide of iron
THERAPEUTIC INDICATIONS:
CAUTION & SCHEDULE:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
STORAGE & DOSAGE:
Dosage: As directed by the Physician

