GENERIC NAME OF THE MEDICINAL PRODUCT:

Montelukast+Levocetirizine+Ambroxol SR Tablet 10mg+5mg+75mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Montelukast+Levocetirizine+Ambroxol SR Tablet 10mg+5mg+75mg
Each uncoated bilayer tablet contains:
Montelukast Sodium IP
equivalent to Montelukast.…………………………….10mg
Levocetirizine Hydrochloride I.P……………………………5mg
Ambroxol Hydrochloride IP……………………………….75mg
(As Sustained release from)
Excipients…………………………………. q.s.
Colours: Lake Ponceau 4R


THERAPEUTIC INDICATIONS:

Ambroxol + Levocetirizine + Montelukast is a combination of three medicines: Ambroxol , Levocetirizine and Montelukast. Ambroxol is a mucolytic which thins and loosens mucus (phlegm), making it easier to cough out. Levocetirizine is an antiallergic which relieves allergy symptoms like 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.

Montelukast+Levocetirizine+Ambroxol SR Tablet Technical Specification:

Product Name:               Montelukast+Levocetirizine+Ambroxol SR Tablet
Brand Name: Generics
Strength: (10mg+5mg+75mg)
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: Expectorant 
Indication: Ambroxol + Levocetirizine + Montelukast is a combination of three medicines: Ambroxol , Levocetirizine and Montelukast. Ambroxol is a mucolytic which thins and loosens mucus (phlegm), making it easier to cough out. Levocetirizine is an antiallergic which relieves allergy symptoms like 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+Levocetirizine+Ambroxol SR Tablet 10mg+5mg+75mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Montelukast+Levocetirizine+Ambroxol SR Tablet 10mg+5mg+75mg
    Each uncoated bilayer tablet contains:
    Montelukast Sodium IP
    equivalent to Montelukast.…………………………….10mg
    Levocetirizine Hydrochloride I.P……………………………5mg
    Ambroxol Hydrochloride IP……………………………….75mg
    (As Sustained release from)
    Excipients…………………………………. q.s.
    Colours: Lake Ponceau 4R

THERAPEUTIC INDICATIONS:

  • Ambroxol + Levocetirizine + Montelukast is a combination of three medicines: Ambroxol , Levocetirizine and Montelukast. Ambroxol is a mucolytic which thins and loosens mucus (phlegm), making it easier to cough out. Levocetirizine is an antiallergic which relieves allergy symptoms like 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.

Introduction to Montelukast+Levocetirizine+Ambroxol SR Tablet 10mg+5mg+75mg

Montelukast+Levocetirizine+Ambroxol SR Tablet 10mg+5mg+75mg is a high-demand combination medicine widely used for respiratory and allergic disorders. It is formulated with Montelukast 10mg, Levocetirizine 5mg, and Ambroxol SR 75mg, targeting multiple pathways to alleviate allergy, asthma, and mucus-related symptoms.

  • Montelukast acts as a leukotriene receptor antagonist, reducing inflammation in airways and preventing asthma attacks.

  • Levocetirizine is an antihistamine that alleviates allergic reactions such as runny nose, sneezing, and watery eyes.

  • Ambroxol SR is a mucolytic agent, thinning and loosening mucus to ease cough and congestion.

This triple-combination therapy is effective in managing both daytime and nighttime nasal symptoms, improving patients’ quality of life. Globally, its demand is rising due to increasing prevalence of asthma, allergic rhinitis, and respiratory infections.


In-Depth Details for Importers, Exporters, and Buyers

Taj Pharma offers comprehensive solutions for international buyers, ensuring seamless import and export processes.

Regulatory Documentation Provided

Taj Pharma provides all essential documents for export compliance:

  • Certificate of Pharmaceutical Product (COPP)

  • Drug Master File (DMF)

  • Clinical Trial Dossiers (CTD)

  • Product registration certificates in target countries

Custom Packaging & Labeling

  • Tailor-made blister packs, bottles, and strips

  • Multilingual labels for target markets

  • Tamper-proof, child-resistant packaging

Shelf-Life, Storage, and Dosage Form

  • Dosage Form: Sustained-release tablets

  • Shelf-life: 24–36 months

  • Storage: Store below 25°C, away from moisture and sunlight

Export Certifications

  • WHO-GMP Certified: Ensures pharmaceutical quality for international standards

  • EU-GMP Certified: For EU import markets

  • ISO 9001 & ISO 14001 Compliance

  • FDA Registration Assistance: On request for US importers

Target Countries & Export Markets

  • Asia: UAE, Saudi Arabia, Sri Lanka, Bangladesh

  • Africa: Nigeria, Kenya, South Africa

  • Europe: Germany, UK, France

  • Americas: USA, Canada, Brazil

Taj Pharma ensures reliable logistics and timely delivery to all global destinations, meeting international quality standards.


Why Taj Pharma is the Most Trusted Manufacturer, Supplier, and Exporter

State-of-the-Art Manufacturing

  • Ultra-modern production facilities in Vapi, Gujarat

  • Fully automated and validated machinery

  • Strict adherence to cGMP and WHO-GMP standards

Affordable Pricing & Quality Assurance

  • Competitive pricing for bulk orders

  • Stringent quality checks at raw material, in-process, and finished product levels

  • ISO-certified quality assurance team

Global Presence & Supply Chain Support

  • Reliable export networks in over 50 countries

  • Efficient logistics to reduce lead times

  • Dedicated international support team

Top 20 Countries Exporting

Nigeria, Kenya, South Africa, Vietnam, Philippines, Iraq, Libya, Uzbekistan, Ghana, Ethiopia, Yemen, Tanzania, Sri Lanka, Afghanistan, Myanmar, Nepal, Kazakhstan, Ecuador, Bangladesh, Dominican Republic

Technical Product Specification Table

Drug Name Composition Dosage Form Strength Packaging Shelf-Life Storage
Montelukast+Levocetirizine+Ambroxol SR Tablet Montelukast 10mg + Levocetirizine 5mg + Ambroxol SR 75mg Sustained-Release Tablet 10mg+5mg+75mg Blister / Strip / Bottle 24–36 Months Below 25°C, Dry Place

Call to Action for Buyers/Distributors

Taj Pharma invites distributors, wholesalers, and global buyers to partner for reliable supply of Montelukast+Levocetirizine+Ambroxol SR Tablet 10mg+5mg+75mg. Contact us today for:

  • Bulk pricing inquiries

  • Product samples

  • Export documentation

  • Custom packaging options

Contact: Taj Pharma Official Website


Top 20 FAQs  

  1. What is Montelukast+Levocetirizine+Ambroxol SR Tablet?
    It’s a combination therapy for asthma, allergies, and respiratory congestion.

  2. Can it be used for children?
    Only as prescribed by a pediatrician.

  3. Is it OTC or prescription-only?
    Prescription-only medicine.

  4. How long before it works?
    Effects are noticeable after several days; it does not provide immediate relief.

  5. Can it replace a rescue inhaler?
    No, continue using your inhaler for sudden asthma attacks.

  6. How should it be stored?
    Store below 25°C, away from sunlight and moisture.

  7. What are the side effects?
    Mild: headache, dizziness, dry mouth, nausea; consult a doctor if severe.

  8. Is it safe for pregnant women?
    Only if prescribed by a doctor; consult your OB-GYN.

  9. Can it be used long-term?
    Yes, under doctor supervision.

  10. Does it affect liver or kidney function?
    Regular monitoring may be recommended.

  11. How often should it be taken?
    As per prescription, usually once daily.

  12. Can it be combined with other antihistamines?
    Only under medical supervision.

  13. Is there a generic version available?
    Yes, manufactured under high-quality standards by Taj Pharma.

  14. Can it cause drowsiness?
    Levocetirizine may rarely cause mild drowsiness.

  15. Is it effective for chronic cough?
    Ambroxol helps in mucus clearance, alleviating cough.

  16. Does it require blood tests?
    Regular monitoring may be advised for long-term therapy.

  17. Can it interact with other medications?
    Yes, always inform your doctor about concurrent medications.

  18. Is it exported globally?
    Yes, Taj Pharma exports to over 50 countries.

  19. Does it have WHO-GMP certification?
    Yes, ensuring international quality standards.

  20. How can I become a distributor?
    Contact Taj Pharma for franchise and supply options.