| Product Name: | Rabeprazole Sodium and Domperidone Capsules |
| Brand Name: | Generic |
| Strength: | 20mg + 30mg |
| Dosage Form: | Capsule (Sustain Release Hard Gelatin Capsule) |
| Route of Administration: | Via Oral route |
| Packing: | 10s, 15s, 30s, |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Treat Gastrointestinal reflux disease |
| Indication: | Used in the treatment of gastroesophageal reflux disease (acid reflux) and peptic ulcer disease. |
| Storage: | Store below 25°C |
Rabeprazole Sodium and Domperidone Capsule Technical Specification:
GENERIC NAME OF THE MEDICINAL PRODUCT:
Rabeprazole Sodium and Domperidone Capsules 20mg + 30mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Each Hard Gelatin Capsule Contains:
Rabeprazole Sodium IP
(Enteric coated pellets).…………….…………………………. 20mg
Domperidone IP (sustained release pellets) ………… 30mg
Colour: Ferric oxide USP-NF (Red), Ferric oxide USP-NF (Yellow) and Titanium Dioxide IP.
Colours used in Shells: Titanium Dioxide IP, Sunset Yellow FCF and Carmoisine.
THERAPEUTIC INDICATIONS:
To treat acidity, heartburn, gastro-esophageal reflux disease (GERD), Zollinger-Ellison syndrome, nausea, vomiting, the fullness of the stomach, bloating, gas, helicobacter pylori infection, gastric and duodenal ulcers.
CAUTION & SCHEDULE:
CAUTION:
Do not chew, crush or break it.
Keep out of reach and sight of children.
SCHEDULE: Schedule H Prescription Drug: Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Keep in cool & dry place.
Protect from heat, light & moisture.
Store in tight container.
Dosage: As directed by the Physician.