Ranitidine Tablets USP 150 mg Technical Specification:
| Product Name: | Ranitidine Tablets USP 150 mg |
| Brand Name: | Generic |
| Strength: | 150mg |
| Dosage Form: | Film Coated Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 40s, 450s, 900s |
| 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: | Antihistaminic, H2 receptor blocker |
| Indication: | To treat gastroesophageal reflux disease (acid reflux) and peptic ulcer disease |
| Storage: | Store at 20° to 25°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Ranitidine Tablets USP 150 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Ranitidine Tablets USP 150 mg
Each Film Coated Tablet Contains:
Ranitidine Hydrochloride USP……………….150 mg
Excipients…………………………………………….Q.S.
Colour: Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
This medication is used to treat certain stomach and throat (esophagus) problems such as erosive esophagitis, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome. It relieves symptoms such as cough that doesn’t go away, stomach pain, heartburn, and difficulty swallowing.
CAUTION & WARNING:
CAUTION:
Keep medicine out of reach of children.
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.