| Product Name: | Rabeprazole Sodium Delayed-Release Tablets |
| Brand Name: | RABTAJ |
| 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), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Ulcer, Antacid, Gastroenterological |
| Indication: | Rabeprazole is used in the treatment of gastroesophageal reflux disease (acid reflux) and peptic ulcer disease. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Rabeprazole Sodium Delayed-Release Tablets 20mg (Rabtaj)
- Rabeprazole Sodium Delayed-Release Tablets 40mg (Rabtaj)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Rabeprazole Sodium Delayed-Release Tablets 20mg
Each delayed Release tablet contains:
Rabeprazole Sodium USP……………….20mg
Excipients……………………………………….q.s.
Color: Ferric oxide yellow - Rabeprazole Sodium Delayed-Release Tablets 40mg
Each delayed Release tablet contains:
Rabeprazole Sodium USP……………….40mg
Excipients……………………………………….q.s.
Color: Ferric oxide yellow
THERAPEUTIC INDICATIONS:
Rabeprazole 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:
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 a tight container.
Dosage: As directed by the Physician.