| Product Name: | Esomeprazole Magnesium Delayed-Release Capsules |
| Brand Name: | Generic |
| Strength: | 20mg, 40mg |
| Dosage Form: | Capsules |
| 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: | Anti-Ulcer, Antacid, Gastroenterological |
| Indication: | Esomeprazole is used to treat conditions where there is too much acid in the stomach. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Esomeprazole Magnesium Delayed-Release Capsules 20mg
- Esomeprazole Magnesium Delayed-Release Capsules 40mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Esomeprazole Magnesium Delayed-Release Capsules 20mg
Each delayed Release capsule contains:
Esomeprazole Magnesium USP
Equivalent to Esomeprazole ……………….20mg
Excipients……………………………………………..q.s.
Approved colours used in hard gelatin capsule shells. - Esomeprazole Magnesium Delayed-Release Capsules 40mg
Each delayed Release capsule contains:
Esomeprazole Magnesium USP
Equivalent to Esomeprazole ……………….40mg
Excipients……………………………………………..q.s.
Approved colours used in hard gelatin capsule shells.
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 & WARNING:
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the Physician.