| Product Name: | Orlistat Capsules USP |
| Brand Name: | Generic |
| Strength: | 60mg, 120mg |
| Dosage Form: | Capsule |
| Route of Administration: | Via Oral Route |
| Packing: | 1 strip of 10 Capsule |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Gastroenterological |
| Indication: | Orlistat is used with an individualized low-calorie, low-fat diet, and exercise program to help people lose weight. Prescription orlistat is used in overweight people who may also have high blood pressure, diabetes, high cholesterol, or heart disease. |
| Storage: | Store at a temperature not exceeding 25℃. Store in a cool, dry & dark place Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Orlistat Capsules USP 60mg
- Orlistat Capsules USP 120mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Orlistat Capsules USP 60mg
Each hard gelatin capsule contains:
Orlistat USP…………………60mg
(as pellets)
Excipients………………….q.s
Colour: Black oxide of iron
B)Orlistat Capsules USP 120mg
Each hard gelatin capsule contains:
Orlistat USP…………………120mg
(as pellets)
Excipients………………….q.s
Colour: Tartrazine
THERAPEUTIC INDICATIONS:
Orlistat is used with an individualized low-calorie, low-fat diet, and exercise program to help people lose weight. Prescription orlistat is used in overweight people who may also have high blood pressure, diabetes, high cholesterol, or heart disease.
CAUTION & SCHEDULE:
CAUTION: Read the enclosed leaflet before use.
Keep medicine out of reach of children.
Capsules are to be swallowed as a whole, and not to be chewed or crushed.
CAUTION: To be sold by retail on the prescription of a Registered Medical Practitioner only. STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding 25℃.
Store in a cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by physician.