Ranitidine Tablets USP 300mg Technical Specification:
| Product Name: | Ranitidine Tablets USP |
| 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: | Gastroenterological, Antacid, Anti-Ulcer |
| Indication: | Ranitidine is a medicine that reduces the amount of acid your stomach makes. It was used for indigestion, heartburn and acid reflux, gastro-oesophageal reflux disease (GORD – this is when you keep getting acid reflux), and to prevent and treat stomach ulcers. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ranitidine Tablets USP 300mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ranitidine Tablets USP 300mg
Each film coated tablet contains:
Ranitidine Hydrochloride USP
Equivalent to Ranitidine 300mg
Excipients q.s.
Colour: Fast green FCF
THERAPEUTIC INDICATIONS:
Ranitidine is a medication used to decrease stomach acid production. It is commonly used in treatment of peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Ranitidine Tablets USP 150mg
B) Ranitidine Tablets USP 300mg
B) Ranitidine Tablets USP 300mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Ranitidine Tablets USP 150mg
Each film coated tablet contains:
Ranitidine Hydrochloride USP
Equivalent to Ranitidine 150mg
Excipients q.s.
Colour: Ponceau 4 R
B) Ranitidine Tablets USP 300mg
Each film coated tablet contains:
Ranitidine Hydrochloride USP
Equivalent to Ranitidine 300mg
Excipients q.s.
Colour: Fast green FCF
Each film coated tablet contains:
Ranitidine Hydrochloride USP
Equivalent to Ranitidine 150mg
Excipients q.s.
Colour: Ponceau 4 R
B) Ranitidine Tablets USP 300mg
Each film coated tablet contains:
Ranitidine Hydrochloride USP
Equivalent to Ranitidine 300mg
Excipients q.s.
Colour: Fast green FCF
THERAPEUTIC INDICATIONS:
Ranitidine is a medication used to decrease stomach acid production. It is commonly used in treatment of peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
