Levocetirizine Hydrochloride & Montelukast Sodium Tablets IP 10mg+5mg Technical Specification:

Product Name:Levocetirizine Hydrochloride & Montelukast Sodium Tablets IP 10mg+5mg
Brand Name:Generics
Strength: (10mg+5mg), (2.5mg+4mg)
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:Antiallergic, Antihistamine
Indication: It treats sneezing, runny nose, and allergic skin conditions due to various allergies and hay fever (seasonal allergy). An allergy is an immune system response to foreign elements typically not harmful to your body. These foreign elements are known as ‘allergens.
Storage:Store below 30˚C. Protect from Light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Levocetirizine Hydrochloride & Montelukast Sodium Tablets IP 10mg+5mg
    Each uncoated tablet contains:
    Montelukast Sodium IP
    equivalent to Montelukast.…………………………….10mg
    Levocetirizine Hydrochloride I.P……………………………5mg
    Excipients…………………………………. q.s.
    Colours: Quinoline Yellow
  • Levocetirizine Hydrochloride & Montelukast Sodium Tablets IP 2.5mg+4mg
    Each uncoated tablet contains:
    Montelukast Sodium IP
    equivalent to Montelukast…………………………….4mg
    Levocetirizine Hydrochloride I.P……………………………2.5mg
    Excipients…………………………………. q.s.
    Colours: Titanium Dioxide IP

THERAPEUTIC INDICATIONS:

Montelukast Sodium and Levocetirizine Hydrochloride Tablets are used in the treatment for conditions like sneezing, runny nose, hay fever, skin allergies, etc. The medication contains two drugs: Levocetirizine (antiallergic) & Montelukast (leukotriene antagonist). Both medicines used in the formulation works differently. Levocetirizine functions by blocking a chemical messenger called histamine that is responsible for watery eyes, runny nose, and sneezing. While Montelukast blocks other chemical messengers (leukotriene) that reduce inflammation in the airways and nose. Therefore, the patient gets relief from symptoms/conditions effectively.

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:  Store below 30˚C. Protect from Light and moisture.

Dosage:  As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Levocetirizine Hydrochloride & Montelukast Sodium Tablets IP 10mg+5mg
B. Levocetirizine Hydrochloride & Montelukast Sodium Tablets IP 2.5mg+4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Levocetirizine Hydrochloride & Montelukast Sodium Tablets IP 10mg+5mg
Each uncoated tablet contains:
Montelukast Sodium IP
equivalent to Montelukast.…………………………….10mg
Levocetirizine Hydrochloride I.P……………………………5mg
Excipients…………………………………. q.s.
Colours: Quinoline Yellow


b) Levocetirizine Hydrochloride & Montelukast Sodium Tablets IP 2.5mg+4mg
Each uncoated tablet contains:
Montelukast Sodium IP
equivalent to Montelukast…………………………….4mg
Levocetirizine Hydrochloride I.P……………………………2.5mg
Excipients…………………………………. q.s.
Colours: Titanium Dioxide IP

THERAPEUTIC INDICATIONS:

Montelukast Sodium and Levocetirizine Hydrochloride Tablet are used in the treatment for conditions like sneezing, runny nose, hay fever, skin allergies, etc. The medication contains two drugs: Levocetirizine (antiallergic) & Montelukast (leukotriene antagonist). Both medicines used in the formulation works differently. Levocetirizine functions by blocking a chemical messenger called histamine that is responsible for watery eyes, runny nose, and sneezing. While Montelukast blocks other chemical messengers (leukotriene) that reduce inflammation in the airways and nose. Therefore, the patient gets relief from symptoms/conditions effectively.

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: Store below 30˚C. Protect from Light and moisture.
Dosage: As directed by the Physician.