ROMILAST L 5 MG TAB

1. All Details: Specifications Active Pharmaceutical Ingredients: Montelukast Sodium IP equivalent to Montelukast and Levocetirizine Dihydrochloride IP. Dosage Form: Uncoated dispersible tablet. Coloring Agents: Sunset Yellow FCF. Storage Environment: Store protected from light and moisture, at a temperature not exceeding . Keep all medicines out of reach of children. Regulatory Classification: SCHEDULE H PRESCRIPTION DRUG – CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner. Manufacturing License Number (Mfg. Lic. No.): G/2242                                                                         2. General Information Brand: ROMILAST® L 5 (stylized as ROMILAST® L 5)Name: Montelukast Sodium and Levocetirizine Dihydrochloride Dispersible Tablets Quantity: Strip of 10 Tablets (indicated by “10 Tablets”).Type: Prescription Anti-allergic / Antiasthmatic Respiratory Medication. Factor (Form Factor): Solid oral tablet (Dispersible formulation).Maximum Shelf Life: Standard pharmaceutical formulations of this category typically maintain a shelf life of 24 to 36 months from production (please refer to the embossed margin stamp on your physical foil pack for the exact batch timeline).Food Preference: Not Applicable. As a prescription therapeutic formulation, standard consumer food/dietary labels (such as a green vegetarian dot) are not utilized. FSSAI: Not Applicable. This drug is strictly governed 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: Ingredients Each uncoated dispersible tablet contains: Montelukast Sodium IP equivalent to Montelukast: Levocetirizine Dihydrochloride IP: Excipients: q. s. (Quantity Sufficient) 4. Directions: How to Use Dosage: As directed by the Physician. Administration Instructions: Since these are designated as dispersible tablets, they should be dissolved in a small quantity of water (usually a teaspoonful) to create a liquid mixture immediately before drinking. Alternatively, they can be taken as instructed by your healthcare professional. Do not crush or chew dry unless explicitly directed. 5. Description: Romilast L 5 is a combined prescription oral medication frequently recommended for the management of allergic rhinitis, hay fever, and comorbid mild allergic asthma. The combination pairs Levocetirizine (a non-sedating, second-generation antihistamine that blocks allergy-triggering histamines) with Montelukast (a leukotriene receptor antagonist that reduces inflammation and swelling in the airways). Because this specific “5” strength features a dispersible matrix, it dissolves quickly in liquid, making it highly suitable for pediatric patients or individuals who find swallowing hard, whole tablets difficult. The packaging contains a clear red warning box signifying its restricted status as a prescription-only drug. 6. Manufacturer Information Manufactured in India by: Adnova Healthcare Pvt. Ltd. Plant Address: 156, 157-A, Sidcul Industrial Infrastructure Park, Waghodia, Vadodara – 391760, Gujarat, India. 7. Marketed By Marketed by: RPG LIFE SCIENCES LIMITED