GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each uncoated bilayer tablet contains:
Montelukast Sodium
equivalent to Montelukast I.P.…………………………….10mg
Levocetirizine Hydrochloride I.P……………………………5mg
Excipients…………………………………. q.s.
Colours: Sunset Yellow FCF
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.
Montelukast Sodium+Levocetirizine Hydrochloride Tablet Technical Specification:
| Product Name: | Montelukast Sodium+Levocetirizine Hydrochloride Tablet |
| Brand Name: | Generics |
| Strength: | (10mg+5mg) |
| Dosage Form: | Tablet (Uncoated) |
| Route of Administration: | Via oral Route |
| Packing: | 10s, 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| 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+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 I.P.…………………………….10mg
Levocetirizine Hydrochloride I.P……………………………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
- SCHEDULE “H” Prescription Drug-Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
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.






