Omeprazole Capsules IP 20mg Technical Specification:
| Product Name: | Omeprazole Capsules IP 20mg |
| Brand Name: | Generic |
| Strength: | 20mg |
| Dosage Form: | Hard Gelatin Capsule |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 15s, 20s, 100s, 150s, 200s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Proton pump inhibitor |
| Indication: | To treat indigestion, heartburn and acid reflux. |
| Storage: | Store below 30°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Omeprazole Capsules IP 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Omeprazole Capsules IP 20mg
Each Hard Gelatin Capsule Contains:
Omeprazole IP……………….20mg
Excipients…………………………Q.S.
Approved colours used in empty capsule shells.
INDICATIONS:
Omeprazole capsule is used to treat certain conditions where there is too much acid in the stomach. It is used to treat gastric and duodenal ulcers, erosive esophagitis and gastroesophageal reflux disease (GERD).
CAUTION & SCHEDULE:
CAUTION:
Keep medicine out of reach of children.
Do not open, chew or crush the capsule. Capsule should be swallowed whole with water.
SCHEDULE:
SCHEDULE H PRESCRIPTION DRUG: WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A registered medical practitioner ONLY.
STORAGE & DOSAGE:
STORAGE: Store below 30°C. Protect from direct light and moisture.
DOSAGE: As directed by the Physician.
