GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Cetirizine HCl IP.…………………………….10mg
Ambroxol HCL IP ……………………………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.
Cetirizine HCl+Ambroxol HCL Tablet 5mg+60mg Technical Specification:
| Product Name: | Cetirizine HCl+Ambroxol HCL Tablet |
| Brand Name: | Generics |
| Strength: | (5mg+60mg) |
| 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: | Cetirizine + Ambroxol is a combination of two medicines: Cetirizine and Ambroxol, which relieves cough. Cetirizine is an antiallergic that treats runny nose, watery eyes and sneezing. Ambroxol is a mucolytic which thins and loosens mucus (phlegm), making it easier to cough out. |
| 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:
- Cetirizine HCl+Ambroxol HCL 5mg+60mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- a) Cetirizine HCl+Ambroxol HCL 5mg+60mg
Each film-coated tablet contains:
Cetirizine HCl IP.…………………………….10mg
Ambroxol HCL IP ……………………………5mg
Excipients…………………………………. q.s.
Colours: Sunset Yellow FCF
THERAPEUTIC INDICATIONS:
- Cetirizine + Ambroxol is a combination of two medicines: Cetirizine and Ambroxol, which relieves cough. Cetirizine is an antiallergic that treats runny nose, watery eyes and sneezing. Ambroxol is a mucolytic which thins and loosens mucus (phlegm), making it easier to cough out.
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 Cetirizine HCl+Ambroxol HCL 5mg+60mg
Cetirizine HCl+Ambroxol HCL 5mg+60mg is a powerful combination medicine widely prescribed for patients suffering from productive cough, seasonal allergies, and respiratory tract congestion. Cetirizine is an antihistamine that reduces allergic reactions like sneezing, watery eyes, and runny nose, while Ambroxol acts as a mucolytic agent, thinning and loosening mucus, making it easier to cough out.
This combination is highly effective for people with allergic cough, bronchitis, chronic obstructive pulmonary disease (COPD), asthma-related cough, and pollen-induced respiratory conditions. Studies also show that cetirizine clinically improves cough due to pollen allergy, making this formulation a highly demanded treatment option globally.
The demand for Cetirizine HCl+Ambroxol HCL 5mg+60mg has been increasing worldwide due to rising cases of allergic rhinitis, asthma, and chronic cough. Importers and distributors seek trusted manufacturers in India with WHO-GMP-approved facilities, long shelf-life products, and global export capabilities. Among all, Taj Pharma Ltd, Vapi, Gujarat, stands out as a leading manufacturer, supplier, and exporter.
In-Depth Details for Importers, Exporters & Buyers
International buyers and distributors require more than just medicines – they need regulatory-compliant, high-quality formulations that meet global standards. Taj Pharma ensures that every consignment of Cetirizine HCl+Ambroxol HCL 5mg+60mg meets the following requirements:
✅ Regulatory Documentation Provided
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Certificate of Pharmaceutical Product (COPP)
-
WHO-GMP Certification
-
EU-GMP Compliance
-
CTD/ACTD Dossier Support
-
Stability Data (Zone II & IV)
-
Free Sale Certificate
✅ Custom Packaging & Labeling
Taj Pharma provides customized packaging and labeling solutions tailored for different markets, including English, French, Spanish, Arabic, and Russian packaging. Blister packs, bottles, and strip packaging are available to meet client requirements.
✅ Shelf-Life, Storage & Dosage Form
-
Dosage Form: Tablet / Capsule (Cetirizine 5mg + Ambroxol 60mg)
-
Shelf-Life: 24–36 months
-
Storage: Store in a cool, dry place away from direct sunlight and moisture.
✅ Export Certifications
Taj Pharma is globally recognized for its export excellence with certifications like:
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WHO-GMP (World Health Organization – Good Manufacturing Practice)
-
EU-GMP (European Union Compliance)
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ISO 9001:2015 Certified
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Drug Master Files (DMF) Support
✅ Target Countries & Export Markets
Taj Pharma exports Cetirizine HCl+Ambroxol HCL 5mg+60mg to more than 40 countries worldwide, including:
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South Asia: Sri Lanka, Nepal, Bangladesh
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Africa: Nigeria, Kenya, South Africa, Ghana, Tanzania
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Middle East: UAE, Saudi Arabia, Iraq, Yemen
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CIS Countries: Kazakhstan, Uzbekistan, Ukraine
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Latin America: Brazil, Chile, Peru
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Europe: UK, Germany, France
Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter
1. State-of-the-Art Manufacturing
Taj Pharma operates ultra-modern WHO-GMP and EU-GMP-certified facilities in Vapi, Gujarat, and Mumbai, Maharashtra. With advanced production units, strict quality control, and R&D capabilities, the company guarantees world-class pharmaceutical formulations.
2. Affordable Pricing & Quality Assurance
Global buyers prefer Taj Pharma for cost-effective, high-quality medicines. The company follows stringent QA/QC protocols ensuring every batch of Cetirizine HCl+Ambroxol HCL 5mg+60mg meets international quality benchmarks.
3. Global Presence & Supply Chain Support
With exports to over 40 countries, Taj Pharma ensures timely delivery, strong logistics support, and regulatory guidance for importers and distributors worldwide.
4. Top 20 Countries Exporting Cetirizine HCl+Ambroxol HCL 5mg+60mg
Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia
Technical Product Specification Table
| Parameter | Details |
|---|---|
| Product Name | Cetirizine HCl + Ambroxol HCL |
| Strength | 5mg + 60mg |
| Dosage Form | Tablet / Capsule |
| Packaging | Blister packs / Strips / Bottles |
| Shelf-Life | 24–36 months |
| Storage Conditions | Store in a cool, dry place; protect from light & moisture |
| Indications | Allergic cough, runny nose, sneezing, congestion, asthma, bronchitis |
| Side Effects | Dry mouth, headache, fatigue, sleepiness, constipation, diarrhea, vomiting |
| Certifications | WHO-GMP, EU-GMP, ISO, COPP, CTD Dossier |
| Manufacturer | Taj Pharma Ltd, Vapi, Gujarat, India |
If you are a pharmaceutical distributor, importer, or PCD Pharma franchise partner looking for a reliable Cetirizine HCl+Ambroxol HCL 5mg+60mg manufacturer in India, Taj Pharma is your trusted partner.
With WHO-GMP-certified facilities, global exports, regulatory support, and competitive pricing, Taj Pharma ensures that you get the best quality medicines at the best value.
📞 Contact Taj Pharma Today to discuss bulk orders, export requirements, or PCD Pharma franchise opportunities.
Top 20 FAQs
Q1: What is Cetirizine HCl+Ambroxol HCL 5mg+60mg used for?
A: It is used to treat productive cough, allergic rhinitis, asthma, and respiratory tract congestion.
Q2: Who is the leading Cetirizine HCl+Ambroxol HCL 5mg+60mg manufacturer in India?
A: Taj Pharma Ltd, Vapi, Gujarat, is the most trusted WHO-GMP-certified manufacturer.
Q3: Can children take this medicine?
A: Yes. Cetirizine liquid is prescribed for children as young as 1 year old. Tablets are suitable for children above 6 years under medical supervision.
Q4: What are the common side effects?
A: Dry mouth, fatigue, headache, diarrhea, constipation, and sleepiness.
Q5: Can this medicine be exported globally?
A: Yes, Taj Pharma exports to over 40 countries.
Q6: What regulatory documents are provided by Taj Pharma?
A: WHO-GMP, COPP, CTD dossier, stability data, and Free Sale Certificate.
Q7: Can this drug cause drowsiness?
A: Yes, cetirizine may cause drowsiness, so patients should avoid alcohol and driving.
Q8: Is it safe to use during pregnancy?
A: Use only under doctor’s supervision.
Q9: What is the shelf life of the product?
A: 24–36 months depending on packaging and storage conditions.
Q10: Can Taj Pharma provide customized packaging?
A: Yes, multilingual packaging is available for export markets.
Q11: Is it suitable for asthma patients?
A: Yes, it helps relieve cough and congestion in asthma patients.
Q12: Can it be taken with alcohol?
A: No, alcohol may increase sleepiness and reduce effectiveness.
Q13: What certifications does Taj Pharma have?
A: WHO-GMP, EU-GMP, ISO, COPP.
Q14: What makes Taj Pharma a preferred supplier?
A: Affordable pricing, strict quality assurance, and strong export capabilities.
Q15: Can it be used for pollen allergy?
A: Yes, cetirizine is clinically proven to help in pollen-induced cough.
Q16: Does Taj Pharma supply to government tenders?
A: Yes, Taj Pharma participates in global healthcare tenders.
Q17: How can distributors contact Taj Pharma?
A: Via the official website or direct export division.
Q18: Is PCD Pharma Franchise available?
A: Yes, Taj Pharma offers lucrative PCD Pharma franchise opportunities.
Q19: What dosage form is available?
A: Tablets and capsules in different packaging options.
Q20: Why choose Taj Pharma over other manufacturers?
A: Because of WHO-GMP quality, global reputation, affordability, and reliability.






