Omeprazole Magnesium & Ondansetron Hydrochloride Tablets 10mg+2mg Technical Specification:
| Product Name: | Omeprazole Magnesium & Ondansetron Hydrochloride Tablets 10mg+2mg |
| Brand Name: | Generics |
| Strength: | (10mg+2mg), (10mg+4mg) |
| Dosage Form: | Tablet (Enteric-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 10s, 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-Ulcer |
| Indication: | This medication is used alone or with other medications to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy) and radiation therapy. It is also used to prevent and treat nausea and vomiting after surgery. Ondansetron works by blocking one of the body’s natural substances (serotonin) that causes vomiting. |
| Storage: | Store in cool, dry & dark place. Protect from Light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Omeprazole Magnesium & Ondansetron Hydrochloride Tablets 10mg+2mg
- Omeprazole Magnesium & Ondansetron Hydrochloride Tablets 10mg+4mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Omeprazole Magnesium & Ondansetron Hydrochloride Tablets 10mg+2mg
Each Enteric-coated Tablet contains:
Omeprazole Magnesium USP
Eq. to Omeprazole………………10mg
Ondansetron Hydrochloride IP
Eq. to Ondansetron………………………2mg
Excipients…………………………q.s.
Colours: Red oxide of iron
- Omeprazole Magnesium & Ondansetron Hydrochloride Tablets 10mg+4mg
Each Enteric-coated Tablet contains:
Omeprazole Magnesium USP
Eq. to Omeprazole………………10mg
Ondansetron Hydrochloride IP
Eq. to Ondansetron………………………4mg
Excipients…………………………q.s.
Colours: Brilliant Blue FCF & Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
This medication is used alone or with other medications to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy) and radiation therapy. It is also used to prevent and treat nausea and vomiting after surgery. Ondansetron works by blocking one of the body’s natural substances (serotonin) that causes vomiting.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Store in a cool, dry & dark place. Protect from Light and moisture.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Omeprazole Magnesium & Ondansetron Hydrochloride Tablets 10mg+4mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Enteric-coated Tablet contains:
Omeprazole Magnesium USP
Eq. to Omeprazole………………10mg
Ondansetron Hydrochloride IP
Eq. to Ondansetron………………………2mg
Excipients…………………………q.s.
Colours: Red oxide of iron
b) Omeprazole Magnesium & Ondansetron Hydrochloride Tablets 10mg+4mg
Each Enteric-coated Tablet contains:
Omeprazole Magnesium USP
Eq. to Omeprazole………………10mg
Ondansetron Hydrochloride IP
Eq. to Ondansetron………………………4mg
Excipients…………………………q.s.
Colours: Brilliant Blue FCF & Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.

