| Product Name: | Montelukast and Levocetirizine Dihydrochloride Dispersible Tablets |
| Brand Name: | Generic |
| Strength: | 2.5mg + 4mg, 5mg + 10mg |
| Dosage Form: | Dispersible Tablet |
| Route of Administration: | Via Oral route |
| Packing: | 15s, 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-allergic, Anti-histaminic and Anti-asthmatic |
| Indication: | To treat sneezing, runny nose and watery eyes. |
| Storage: | Store below 30°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Montelukast and Levocetirizine Dihydrochloride Dispersible Tablets 2.5mg + 4mg
B. Levocetirizine and Montelukast Tablets IP 5mg + 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Each Uncoated Dispersible Tablet Contains:
Montelukast Sodium IP
eq. to Montelukast ………………………….4mg
Levocetirizine Dihydrochloride IP.…….2.5mg
Excipients …………………………….……………. Q.S.
Colour: Ferric Oxide Yellow USP-NF
THERAPEUTIC INDICATIONS:
To treat the symptoms of Chronic Urticaria, Obstructive Airway Diseases, Chronic Asthma and Rhinitis.
CAUTION & SCHEDULE:
CAUTION:
Keep out of reach of children.
Schedule H Prescription Drug: Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Protect from light & moisture, at a temperature not exceeding 30 ˚C.
Dosage: As directed by the Physician.