| Product Name: | Montelukast Sodium Tablets USP |
| Brand Name: | Generic |
| Strength: | 5mg, 10mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Asthmatic |
| Indication: | Montelukast helps stop your airways from narrowing (caused by inflammation). This makes breathing easier and prevents asthma attacks. Most people take montelukast once a day in the evening. If you take it for asthma, it’s important to take it even when you have no symptoms. |
| Storage: | Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Montelukast Sodium Tablets USP 5mg
- Montelukast Sodium Tablets USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Montelukast Sodium Tablets USP 5mg
Each Film-coated tablet contains:
Montelukast Sodium USP 5.2mg
Equivalent to Montelukast……….4mg
Excipients………………………………..q.s
Colour: Sunset yellow FCF - Montelukast Sodium Chewable Tablets USP 10mg
Each Film-coated tablet contains:
Montelukast Sodium USP 10.4mg
Equivalent to Montelukast……….5mg
Excipients………………………………..q.s
Colour: Sunset yellow
THERAPEUTIC INDICATIONS:
Montelukast helps stop your airways from narrowing (caused by inflammation). This makes breathing easier and prevents asthma attacks. Most people take montelukast once a day in the evening. If you take it for asthma, it’s important to take it even when you have no symptoms.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINED IN THE USP.
Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.