A) Ranitidine Tablets 150mg
B) Ranitidine Tablets 300mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Ranitidine Tablets 150mg
Each Film-coated tablet contains:
Ranitidine Hydrochloride USP………168mg
Equivalent to Ranitidine………………..150mg
Excipients………………………………..…….q.s.
Colour: Sunset Yellow Lake and Titanium Dioxide USP
B) Ranitidine Tablets 300mg
Each Film-coated tablet contains:
Ranitidine Hydrochloride USP
Equivalent to Ranitidine………………..300mg
Excipients………………………………..…….q.s.
Colour: Indigo Carmine
Each Film-coated tablet contains:
Ranitidine Hydrochloride USP………168mg
Equivalent to Ranitidine………………..150mg
Excipients………………………………..…….q.s.
Colour: Sunset Yellow Lake and Titanium Dioxide USP
B) Ranitidine Tablets 300mg
Each Film-coated tablet contains:
Ranitidine Hydrochloride USP
Equivalent to Ranitidine………………..300mg
Excipients………………………………..…….q.s.
Colour: Indigo Carmine
THERAPEUTIC INDICATIONS:
Ranitidine is used to treat ulcers of the stomach and intestine and prevent them from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn't go away, stomach pain, heartburn, and difficulty swallowing.
DIRECTIONS:
Adults and children over 12 years: Swallow tablet whole with a drink of water(do not chew), as soon as you have any symptoms at any time day or night.
Do not take more than 2 tablets in 24 hours.
Do not take more than 2 tablets in 24 hours.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: If symptoms persist see your doctor/healthcare professional.
This preparation is for the relief of minor and temporary ailment and should be used strictly as directed.
Prolonged use without medical supervision could be harmful.
Read enclosed leaflet before use.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: If symptoms persist see your doctor/healthcare professional.
This preparation is for the relief of minor and temporary ailment and should be used strictly as directed.
Prolonged use without medical supervision could be harmful.
STORAGE & DOSAGE:
Storage: Store at a colol and dry place.
Protect from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Protect from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Ranitidine Tablets 150mg Technical Specification:
| Product Name: | Ranitidine Tablets |
| Brand Name: | Generic |
| Strength: | 150mg, 300mg |
| Dosage Form: | Tablets (Film-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, Gastroenterology |
| Indication: | Ranitidine is used to treat ulcers of the stomach and intestine and prevent them from coming back after they have healed. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Protect From light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ranitidine Tablets 150mg
- Ranitidine Tablets 300mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ranitidine Tablets 150mg
Each Film-coated tablet contains:
Ranitidine Hydrochloride USP………168mg
Equivalent to Ranitidine………………..150mg
Excipients………………………………..…….q.s.
Colour: Sunset Yellow Lake and Titanium Dioxide USP - Ranitidine Tablets 300mg
Each Film-coated tablet contains:
Ranitidine Hydrochloride USP
Equivalent to Ranitidine………………..300mg
Excipients………………………………..…….q.s.
Colour: Indigo Carmine
THERAPEUTIC INDICATIONS:
Ranitidine is used to treat ulcers of the stomach and intestine and prevent them from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn’t go away, stomach pain, heartburn, and difficulty swallowing.
DIRECTIONS:
Adults and children over 12 years: Swallow tablet whole with a drink of water(do not chew), as soon as you have any symptoms at any time day or night.
Do not take more than 2 tablets in 24 hours.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: If symptoms persist see your doctor/healthcare professional.
This preparation is for the relief of minor and temporary ailment and should be used strictly as directed.
Prolonged use without medical supervision could be harmful.
STORAGE & DOSAGE:
Storage: Store at a colol and dry place.
Protect from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
