Montelukast Sodium + Levocetirizine Hydrochloride Tablet 10mg+5mg Technical Specification:
Product Name: | Montelukast Sodium + Levocetirizine Hydrochloride Tablet 10mg+5mg |
Brand Name: | MONTICAS |
Strength: | (10mg+5mg) |
Dosage Form: | Tablets(uncoated) |
Route of Administration: | Via oral route |
Packing: | 30s, 90s, 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: | Levocetirizine + Montelukast is a combination of two medicines: Levocetirizine and Montelukast, which relieves sneezing and runny nose due to allergies. Levocetirizine is an antiallergic which blocks a chemical messenger (histamine) responsible for runny nose, watery eyes and sneezing. |
Storage: | Do not store above 25°C. Store in the original package in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Montelukast Sodium+Levocetirizine Hydrochloride Tablet 10mg+5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Montelukast Sodium+Levocetirizine Hydrochloride Tablet 10mg+5mg
Each uncoated bilayer tablet contains:
Montelukast Sodium
Equivalent to Montelukast USP.…………………………….10mg
Levocetirizine Hydrochloride USP……………………………5mg
Excipients…………………………………. q.s.
Colours: Sunset Yellow FCF
THERAPEUTIC INDICATIONS:
Levocetirizine + Montelukast is a combination of two medicines: Levocetirizine and Montelukast, which relieves sneezing and runny nose due to allergies. Levocetirizine is an antiallergic which blocks a chemical messenger (histamine) responsible for runny nose, watery eyes and sneezing.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Do not store above 25°C. Store in the original package in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Montelukast Sodium+Levocetirizine Hydrochloride Tablet 10mg+5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Montelukast Sodium+Levocetirizine Hydrochloride Tablet 10mg+5mg
Each uncoated bilayer tablet contains:
Montelukast Sodium
equivalent to Montelukast USP.…………………………….10mg
Levocetirizine Hydrochloride USP……………………………5mg
Excipients…………………………………. q.s.
Colours: Sunset Yellow FCF
Each uncoated bilayer tablet contains:
Montelukast Sodium
equivalent to Montelukast USP.…………………………….10mg
Levocetirizine Hydrochloride USP……………………………5mg
Excipients…………………………………. q.s.
Colours: Sunset Yellow FCF
THERAPEUTIC INDICATIONS:
Levocetirizine + Montelukast is a combination of two medicines: Levocetirizine and Montelukast, which relieves sneezing and runny nose due to allergies. Levocetirizine is an antiallergic which blocks a chemical messenger (histamine) responsible for runny nose, watery eyes and sneezing.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Do not store above 25°C. Store in the original package in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.