Montelukast Sodium Tablets USP 5mg Technical Specification:

Product Name:Montelukast Sodium Tablets USP 5mg
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

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

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.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Montelukast Sodium Tablets USP 5mg
B. Montelukast Sodium Tablets USP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. 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


B. 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.
Attach dispensing label as per end country.