GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Montelukast Sodium Chewable Tablets USP 4mg
2. Montelukast Sodium Chewable Tablets USP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Montelukast Sodium Chewable Tablets USP 4mg
Each Un-coated Chewable tablet contains:
Montelukast Sodium IP
Equivalent to Montelukast………4mg
Excipients………………………………..q.s
Colour: Titanium Dioxide IP

Montelukast Sodium Chewable Tablets USP 5mg
Each Un-coated Chewable tablet contains:
Montelukast Sodium IP
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 & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
FOR PAEDIATRIC USE ONLY.
SCHEDULE: SCHEDULE H CAUTION: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store below 25°C.
Protect from Light and moisture.
Dosage: As directed by the Physician.

Montelukast Sodium Chewable Tablets USP 4mg Technical Specification:

Product Name: Montelukast Sodium Chewable Tablets USP
Brand Name: Generic
Strength: (4mg), (5mg)
Dosage Form: Tablets(Un-coated Chewable)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Documents: COA, MOA, Stability Studies, GMP
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 below 25°C. Protect from Light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Montelukast Sodium Chewable Tablets USP 4mg
2. Montelukast Sodium Chewable Tablets USP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Montelukast Sodium Chewable Tablets USP 4mg
Each Un-coated Chewable tablet contains:
Montelukast Sodium IP
Equivalent to Montelukast………4mg
Excipients………………………………..q.s
Colour: Titanium Dioxide IP

2.Montelukast Sodium Chewable Tablets USP 5mg
Each Un-coated Chewable tablet contains:
Montelukast Sodium IP
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 & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
FOR PAEDIATRIC USE ONLY.

SCHEDULE: SCHEDULE H CAUTION: TO BE SOLD BY RETAIL on THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store below 25°C.
Protect from Light and moisture.

Dosage: As directed by the Physician.