1. All Details: Specifications
Active Pharmaceutical Ingredient: Rosuvastatin Calcium IP equivalent to Rosuvastatin).Dosage Form: Film-coated tablet. Coloring Agents: Ferric Oxide (Red) USP-NF.Storage Environment: Store at room temperature, protected from light and moisture.Regulatory Classification: CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.Batch Identification: B.No.: SIG0523A.Date of Manufacture (Mfg.Dt.): 03/2025.Date of Expiration (Exp.Dt.): 08/2027.Maximum Retail Price (M.R.P.): Rs. 655.00 per 10 Tablets (Inclusive of all taxes).Manufacturing License Number (M.L.): M/645/2014. 2. General Information
Brand: Rozavel® 40Name: Rosuvastatin Tablets IPQuantity: Strip of 10 Tablets (indicated by “per 10 Tabs.” on the price stamp).Type: Prescription Lipid-Lowering Cardiovascular Medication (High-potency HMG-CoA reductase inhibitor / Statin).Factor (Form Factor): Solid oral tablet (Film-coated).Maximum Shelf Life: 29 months (From March 2025 to August 2027).Food Preference: Not Applicable. This is a chemical prescription drug, meaning standard consumer dietary indicators (such as a green vegetarian dot) are absent.FSSAI: Not Applicable. This therapeutic agent is regulated under the Drugs and Cosmetics Act by the CDSCO. It is not a food supplement, so it does not fall under the licensing framework of the FSSAI (Food Safety and Standards Authority of India).
3. Product Details:
IngredientsEach film-coated tablet contains: Rosuvastatin Calcium IP equivalent to Rosuvastatin: Excipients: q.s. (Quantity Sufficient)
4. Directions:
How to UseDosage: As directed by the Physician. Administration Instructions: The tablet must be swallowed whole with a glass of water and can be taken with or without food. It is highly recommended to take it at the same time every day (often in the evening, as advised by your doctor). Do not crush, split, or chew the tablet before swallowing to protect the film coating.
5. Description
Rozavel 40 is a high-dose prescription oral medication containing of Rosuvastatin. This strength represents the maximum standard daily dose of this particular statin and is typically reserved for patients requiring aggressive management of severe hypercholesterolemia (high cholesterol) or mixed dyslipidemia. It acts directly in the liver to drastically cut down the synthesis of low-density lipoprotein (“bad” cholesterol) and triglycerides while moderately boosting high-density lipoprotein (“good” cholesterol). It is a vital tool for preventing adverse cardiovascular events like myocardial infarctions (heart attacks) and strokes in high-risk individuals. The packaging includes a prominent red warning banner noting its restricted prescription status, an identification grid, and a verification QR code to check product authenticity .
6. Manufacturer Information Manufactured in India by: sun pharma laboratories ltd.Plant Address: Plot No. 107-108, Namli Block, P.O. Ranipool, Gangtok, Sikkim – 737 135.Internal Code Reference: 5249124
7. Marketed ByMarketed by: SUN PHARMA LABORATORIES LTD.
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