GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Montelukast Sodium Sachet 4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Montelukast Sodium Sachet
Each sachet contains 4.2 mg
Montelukast Sodium USP
equivalent to 4 mg Montelukast.
Excipients: Mannitol, Hydroxypropyl Cellulose and Magnesium Stearate.

THERAPEUTIC INDICATIONS:

Montelukast granules come in a sachet with 4mg of granules inside (one dose). You can put them directly on your child's tongue. You can also mix the granules with a spoonful of cold, soft food, such as yoghurt or ice-cream. Make sure your child takes the whole dose immediately (or within 15 minutes).

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
For Pediatric Patients 6 months to 5 years of age.
WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light.
Dosage: Dosage: As directed by the Physician.

Montelukast Sodium Sachet 4mg Technical Specification:

Product Name:Montelukast Sodium Sachet
Brand Name:Generic
Strength:4mg
Dosage Form:Sachets
Route of Administration:Via Oral Route
Packing:1g
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Stability Studies, GMP, CTD Dossier, COPP
Therapeutic use:Leukotriene Receptor Antagonists
Indication:Montelukast granules come in a sachet with 4mg of granules inside (one dose). You can put them directly on your child’s tongue. You can also mix the granules with a spoonful of cold, soft food, such as yoghurt or ice-cream. Make sure your child takes the whole dose immediately (or within 15 minutes).
Storage:Store at a temperature not exceeding 25°C.Protect from light & moisture. Keep out of reach of children.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Montelukast Sodium Sachet 4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Montelukast Sodium Sachet
    Each sachet contains 4.2 mg
    Montelukast Sodium USP
    equivalent to 4 mg Montelukast.
    Excipients: Mannitol, Hydroxypropyl Cellulose and Magnesium Stearate.

THERAPEUTIC INDICATIONS:

Montelukast granules come in a sachet with 4mg of granules inside (one dose). You can put them directly on your child’s tongue. You can also mix the granules with a spoonful of cold, soft food, such as yoghurt or ice-cream. Make sure your child takes the whole dose immediately (or within 15 minutes).

CAUTION & WARNING:

CAUTION:Read enclosed leaflet before use.
For Pediatric Patients 6 months to 5 years of age.
WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A registered medical PRACTITIONER.

STORAGE & DOSAGE:

Storage:Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Protect from moisture and light.
Dosage:As directed by the Physician.