A. Ondansetron Oral Solution USP 2mg/5ml
B. Ondansetron Oral Solution USP 4mg/5ml
GENERIC NAME OF MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Ondansetron Oral Solution USP 2mg/5ml
Composition:
Each 5ml contains:
Ondansetron HCl dihydrate………2.5mg
Eq. to Ondansetron ………………...2mg
Excipients……………………...q.s.
Flavored Syrup Base
B. Ondansetron Oral Solution USP 4mg/5ml
Composition:
Each 5ml contains:
Ondansetron HCl dihydrate………5mg
Eq. to Ondansetron ………………...4mg
Excipients……………………...q.s.
Flavored Syrup Base
Composition:
Each 5ml contains:
Ondansetron HCl dihydrate………2.5mg
Eq. to Ondansetron ………………...2mg
Excipients……………………...q.s.
Flavored Syrup Base
B. Ondansetron Oral Solution USP 4mg/5ml
Composition:
Each 5ml contains:
Ondansetron HCl dihydrate………5mg
Eq. to Ondansetron ………………...4mg
Excipients……………………...q.s.
Flavored Syrup Base
THERAPEUTIC INDICATION:
Ondansetron is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery.
DIRECTION OF USE:
Shake well before using. Use a medicine spoon or syringe to measure your medicine. Do not use household spoons as they may not be accurate. Do not take with carbonated drinks as it may cause throat and gastric irritation.
CAUTION & WARNING:
CAUTION: For pediatric use only.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
STORAGE AND DOSAGE:
STORAGE: Store in a dry place at a temperature below 30°C.
Protect from light.
Store bottles upright.
DOSAGE: As directed by physician.
Protect from light.
Store bottles upright.
DOSAGE: As directed by physician.
Ondansetron Oral Solution USP 2mg/5ml Technical Specification:
| Product Name: | Ondansetron Oral Solution USP 2mg/5ml |
| Brand Name: | Entrostaj |
| Strength: | 2mg/5ml, 4mg/5ml |
| Dosage Form: | Syrup |
| Packing: | 30ml, 50ml |
| Route of Administration: | For Oral Syrup. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antiemetics |
| Indication: | Ondansetron is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. |
| Storage: | Store in a dry place at a temperature below 30°C. Protect from light. Store bottles upright. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Ondansetron Oral Solution USP 2mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ondansetron Oral Solution USP 2mg/5ml
Composition:
Each 5ml contains:
Ondansetron HCl dihydrate………2.5mg
Eq. to Ondansetron …………………2mg
Excipients………………………q.s.
Flavored Syrup Base
THERAPEUTIC INDICATION:
Ondansetron is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery.
DIRECTION OF USE:
Shake well before using. Use a medicine spoon or syringe to measure your medicine. Do not use household spoons as they may not be accurate. Do not take with carbonated drinks as it may cause throat and gastric irritation.
CAUTION & WARNING:
CAUTION: For pediatric use only.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
STORAGE AND DOSAGE:
STORAGE: Store in a dry place at a temperature below 30°C. Protect from light. Store bottles upright.
DOSAGE: As directed by physician.
