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

Product Name:                                                  Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP 10mg+5mg
Brand Name:Montutaj-LC
Strength:(10mg+5mg), (2.5mg+4mg)
Dosage Form:Tablet (film-coated)
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
Indication: Combination therapy (montelukast + levocetirizine) is a more effective strategy than monotherapy in the treatment of persistent allergic rhinitis.
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:

  • Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP 10mg+5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP 10mg+5mg
    Each film-coated tablet contains:
    Montelukast Sodium I.P.
    equivalent to Montelukast …………………………….10mg
    Levocetirizine Dihydrochloride I.P……………………………5mg
    Excipients…………………………………. q.s.
    Colours: Sunset Yellow FCF

THERAPEUTIC INDICATIONS:

It’s usually prescribed when asthma is mild and can stop it from getting worse. It can also help people with asthma who have breathing difficulties when they exercise (exercise-induced asthma) and seasonal allergies, such as sneezing, itchiness and a blocked or runny nose (allergic rhinitis).

CAUTION & SCHEDULE :

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

Read enclosed leaflet before use.

SCHEDULE “H” Prescription Drug -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.

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP 10mg+5mg
Each film-coated tablet contains:
Montelukast Sodium I.P.
equivalent to Montelukast …………………………….10mg
Levocetirizine Dihydrochloride I.P……………………………5mg
Excipients…………………………………. q.s.
Colours: Sunset Yellow FCF


B. Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP 2.5mg+4mg
Each film-coated tablet contains:
Montelukast Sodium
equivalent to Montelukast…………………………….2.5mg
Levocetirizine Hydrochloride……………………………5mg
Excipients…………………………………. q.s.
Colours: Quinoline Yellow

THERAPEUTIC INDICATIONS:

It's usually prescribed when asthma is mild and can stop it from getting worse. It can also help people with asthma who have breathing difficulties when they exercise (exercise-induced asthma) and seasonal allergies, such as sneezing, itchiness and a blocked or runny nose (allergic rhinitis).

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
SCHEDULE “H” Prescription Drug -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.