MONOTRATE 20

1. All Details: Specifications

Active Pharmaceutical Ingredients: Diluted Isosorbide Mononitrate IP equivalent to Isosorbide Mononitrate .Dosage Form: Uncoated tablet.Storage Environment: Store at a temperature not exceeding 30°C. Keep out of reach of children.Regulatory Classification: SCHEDULE H DRUG – WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.Manufacturing License Number (M. L.): 374/DR/Mfg/2013.Internal Material Reference: PESPF0004.

2. General Information

Brand: MONOTRATE® 20 (stylized with a registered trademark symbol).Name: Isosorbide Mononitrate Tablets IP.Quantity: Standard pharmaceutical blister format strip.Type: Prescription Cardiovascular Nitrate Medication (Vasodilator).Factor (Form Factor): Solid oral tablet (Uncoated configuration).Maximum Shelf Life: Explicit manufacturing or expiration dates are not fully visible in this specific framing portion of the strip; however, it remains commercially viable within standard drug stability guidelines.Food Preference: Not Applicable. As a critical prescription cardiovascular chemical formulation, standard consumer retail dietary icons (such as green vegetarian markers) are not utilized.FSSAI: Not Applicable. This high-potency drug is strictly regulated under the Drugs and Cosmetics Act by the CDSCO. It is a pharmaceutical treatment for chronic illness, not a dietary or health supplement, which means it bypasses the licensing framework of the FSSAI (Food Safety and Standards Authority of India).

3. Product Details:

IngredientsEach uncoated tablet contains:Diluted Isosorbide Mononitrate IP equivalent to Isosorbide Mononitrate Excipients: q.s. (Quantity Sufficient)

4. Directions: How to UseDosage: As directed by the Physician.Administration Instructions: The tablet should be swallowed whole with water, preferably at the same times each day as prescribed. It is frequently scheduled with an asymmetric dosing interval (an “eccentric” schedule, such as 7 AM and 2 PM) to provide a necessary nitrate-free interval, preventing the body from developing drug tolerance. Do not crush, chew, or split the tablet unless specifically advised by a physician.

5. Description

Monotrate 20 is an oral prescription medication containing of Isosorbide Mononitrate, an active organic nitrate vasodilator. It is clinically indicated for the prophylactic treatment and long-term management of angina pectoris (heart-related chest pain) caused by coronary artery disease. It operates by releasing nitric oxide into vascular smooth muscle, causing relaxation and dilation of blood vessels. This reduces cardiac workload, lowers myocardial oxygen demand, and improves blood flow to the heart muscle. The silver foil backing features a prominent red boundary line highlighting its Schedule H prescription status alongside registered corporate markings.

6. Manufacturer Information

Manufactured in India by: sun pharma laboratories ltd.Plant Address: Vill: Kokjhar, Mirza Palashbari Road, P.O.: Palashbari, Dist.: Kamrup, Assam-781128.

7. Marketed ByMarketed by: sun pharma laboratories ltd.