GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Montelukast Sodium and Levocetirizine Hydrochloride Tablets (4mg+2.5mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film coated tablet contains:
Levocetirizine Hydrochloride USP……………………………5mg
Montelukast Sodium USP
equivalent to Montelukast.…………………………….10mg
Excipients…………………………………. q.s.
Colours: Sunset Yellow FCF
B. Montelukast Sodium and Levocetirizine Hydrochloride Tablets (4mg+2.5mg)
Each uncoated tablet contains:
Levocetirizine Hydrochloride USP……………………………2.5mg
Montelukast Sodium USP
equivalent to Montelukast.…………………………….4mg
Excipients…………………………………. q.s.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Read enclosed leaflet before use.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
STORAGE & DOSAGE:
Do not freeze.
Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Note: 1 Tablet daily.
Montelukast Sodium and Levocetirizine Hydrochloride Tablets (10mg+5mg) Technical Specification:
Product Name: | Montelukast Sodium and Levocetirizine Hydrochloride Tablets (10mg+5mg) |
Brand Name: | Xeglyart |
Strength: | (10mg+5mg), (4mg+2.5mg) |
Dosage Form: | Tablet (Film-coated, Uncoated) |
Route of Administration: | Via oral Route |
Packing: | 10s, 30s, 100s |
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: | Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Montelukast Sodium and Levocetirizine Hydrochloride Tablets (10mg+5mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Montelukast Sodium and Levocetirizine Hydrochloride Tablets (10mg+5mg)
Each film coated tablet contains:
Levocetirizine Hydrochloride USP……………………………5mg
Montelukast Sodium USP
equivalent to Montelukast.…………………………….10mg
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: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Note: 1 Tablet daily.