Rabeprazole Sodium Delayed Release Tablets USP 20mg Technical Specification:
| Product Name: | Rabeprazole Sodium Delayed Release Tablets USP 20mg |
| Brand Name: | Generic |
| Strength: | 20mg |
| Dosage Form: | Delayed Release Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 90s, 100s, 140s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | Proton-pump inhibitor, Antiulcer |
| Indication: | To treat stomach and esophageal issues |
| Storage: | Store at 20° to 25°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Rabeprazole Sodium Delayed Release Tablets USP 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Rabeprazole Sodium Delayed Release Tablets USP 20mg
Each Delayed Release Tablets Contains
Rabeprazole Sodium USP………………20mg
Excipients……………………………………Q.S.
Colour: Ferric Oxide Yellow USP-NF
THERAPEUTIC INDICATIONS:
It is used to treat stomach and esophagus problems such as acid reflux, ulcers. It relieves symptoms such as heartburn, difficulty swallowing and cough and helps to heal acid damage in the stomach and esophagus, helps prevent ulcers and prevent cancer of the esophagus.
CAUTION & WARNING:
CAUTION:
Keep medicine out of reach of children.
Swallow the tablet whole. Do not crush or chew the tablet.
WARNING:
TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
STORAGE: Store at 25°C (77°F); excursion permitted to 15° to 30° (59-86°F). Protect from light.
DOSAGE: As directed by the Physician.