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.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Montelukast Sodium and Levocetirizine Hydrochloride Tablets (10mg+5mg)
B. Montelukast Sodium and Levocetirizine Hydrochloride Tablets (4mg+2.5mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. 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


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:

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.