GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP (5mg+120mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP (5mg+120mg)
Each Un-coated, Extended-Release tablet contains:
Cetirizine HCL USP ………………………………..5mg
Pseudoephedrine HCL USP ………………..….120mg


THERAPEUTIC INDICATIONS:

Cetirizine and pseudoephedrine is a combination of an antihistamine and a decongestant used to treat the symptoms of seasonal or yearly allergies. Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F).
Dosage: As directed by the Physician
Attach dispensing label as per end county.

Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP (5mg+120mg) Technical Specification:

Product Name: Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP
Brand Name: Generic
Strength: 5mg+120mg
Dosage Form: Tablets (Extended Release)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 50s, 100s, 500s
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-histamine
Indication: Cetirizine and pseudoephedrine is a combination of an antihistamine and a decongestant used to treat the symptoms of seasonal or yearly allergies. Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body.
Storage: Store at 20° to 25°C (68° to 77°F).

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP (5mg+120mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP (5mg+120mg)
    Each Un-coated, Extended-Release tablet contains:

    Cetirizine HCL USP ………………………………..5mg
    Pseudoephedrine HCL USP ………………..….120mg

THERAPEUTIC INDICATIONS:

  • Cetirizine and pseudoephedrine is a combination of an antihistamine and a decongestant used to treat the symptoms of seasonal or yearly allergies. Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body.

CAUTION & WARNING:

  • CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
  • Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

  • Storage: Store at 20° to 25°C (68° to 77°F).
  • Dosage: As directed by the Physician

Attach dispensing label as per end county.

Introduction to Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP (5mg+120mg)

Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP (5mg+120mg) is a widely used prescription medicine that combines an antihistamine (Cetirizine HCL) with a decongestant (Pseudoephedrine HCL) in an extended-release formulation. This combination is primarily used for the treatment of allergic rhinitis, sinusitis, nasal congestion, and other upper respiratory tract allergies.

The Cetirizine HCL component works by blocking histamine receptors to reduce allergy symptoms such as sneezing, runny nose, and itching. The Pseudoephedrine HCL component constricts blood vessels in the nasal passages to relieve congestion, ensuring fast and long-lasting symptom control. Extended-release technology allows for sustained action over 12–24 hours, providing patient convenience and improved compliance.

The global demand for this combination is increasing due to rising allergy prevalence, urban pollution, and seasonal flu outbreaks. Countries across Asia, Europe, Africa, and the Americas rely on quality manufacturers from India to supply this essential medication.

Taj Pharma, a renowned Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP (5mg+120mg) Manufacturer in India, guarantees pharmaceutical-grade purity, safety, and adherence to international standards, making it a preferred choice for buyers and distributors worldwide.


About Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP (5mg+120mg) – Uses & Benefits

Taj Pharma is a well-established Manufacturer, Exporter, and Supplier of Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP (5mg+120mg) from Vapi, Gujarat, India. This tablet offers:

  • Relief from seasonal and perennial allergic rhinitis

  • Reduction of nasal congestion and sinus pressure

  • Improvement of quality of life in patients with respiratory allergies

  • Long-acting effect due to extended-release formulation

Common Side Effects

Most side effects are mild and temporary. Patients are advised to consult a doctor if they persist:

  • Sleepiness or drowsiness

  • Headache

  • Dizziness

  • Insomnia (rare)

Patients should avoid alcohol while taking the medication and consult a healthcare professional if pregnant, breastfeeding, or suffering from cardiovascular conditions.


In-Depth Details for Importers, Exporters & Buyers

Regulatory Documentation Provided

As a reliable Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP (5mg+120mg) Manufacturer & Supplier in India, Taj Pharma ensures all necessary documentation for international trade:

  • Certificate of Pharmaceutical Product (COPP)

  • WHO-GMP Certificate

  • EU-GMP Certification (where applicable)

  • Certificate of Analysis (CoA)

  • Stability Study Reports

  • Material Safety Data Sheet (MSDS)

  • Complete technical dossier for registration

Custom Packaging & Labeling

Taj Pharma offers comprehensive packaging options to meet specific market requirements:

  • Alu-Alu blister packs

  • Strip packs

  • Bulk packaging for hospitals and wholesalers

  • Multilingual labels and artwork compliance

  • Private labeling and branding solutions

Shelf-Life, Storage & Dosage Form

  • Dosage Form: Extended-Release Tablet

  • Strength: Cetirizine 5mg + Pseudoephedrine 120mg

  • Shelf Life: 24–36 months

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

Export Certifications

Taj Pharma supports exports with globally recognized certifications:

  • WHO-GMP Certification

  • CTD / ACTD Dossier Support

  • COPP Certificate for regulated markets

  • DMF support for international regulatory filings

Target Countries & Export Markets

Taj Pharma actively exports Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP (5mg+120mg) from India to Asia, Africa, Latin America, the Middle East, and select regulated markets.


Why Taj Pharma is the Most Trusted Manufacturer & Supplier

State-of-the-Art Manufacturing Facilities

Taj Pharma operates advanced pharmaceutical manufacturing units in Vapi, Gujarat. The facilities feature cutting-edge machinery, validated production processes, and stringent quality control to ensure consistent product quality.

Affordable Pricing & Quality Assurance

As a leading Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP (5mg+120mg) Manufacturer in India, Taj Pharma offers competitive pricing without compromising on quality, enabling distributors to penetrate global markets effectively.

Global Presence & Supply Chain Support

Taj Pharma ensures:

  • Timely dispatch and delivery

  • Flexible minimum order quantities

  • Comprehensive export documentation

  • End-to-end supply chain management

Top 20 Export Countries

Nigeria || Kenya || Ghana || Uganda || South Africa || UAE || Saudi Arabia || Oman || Qatar|| Kuwait || Russia || Kazakhstan || Uzbekistan || Kyrgyzstan || Vietnam || Philippines || Myanmar || Sri Lanka || Peru || Chile ||


Technical Product Specification Table

Parameter Details
Product Name Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP
Strength Cetirizine 5mg + Pseudoephedrine 120mg
Dosage Form Extended-Release Tablet
Therapeutic Class Antihistamine + Decongestant
Route of Administration Oral
Shelf Life 24–36 Months
Storage Below 25°C
Packaging Blister / Bulk
Manufacturer Taj Pharma Ltd, India
Certification WHO-GMP, COPP
Export Availability PAN India & Global

Call to Action

If you are looking for a reliable Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP (5mg+120mg) Manufacturer, Supplier, and Exporter from India, Taj Pharma is your trusted partner.

📩 Contact Taj Pharma today for product samples, technical dossiers, pricing information, or PCD Pharma Franchise opportunities to expand your pharmaceutical portfolio globally.


Top 20 FAQs

  1. What is Cetirizine HCL and Pseudoephedrine HCL ER Tablet USP used for?
    It is used to relieve allergy symptoms and nasal congestion.

  2. Is it a prescription medicine?
    Yes, it must be taken under medical supervision.

  3. Who is a leading manufacturer in India?
    Taj Pharma is a recognized manufacturer and exporter.

  4. Does it cause drowsiness?
    Mild drowsiness may occur in some patients.

  5. Can alcohol be consumed with this tablet?
    No, avoid alcohol to prevent excessive drowsiness.

  6. What certifications does Taj Pharma provide?
    WHO-GMP, COPP, CoA, and export dossiers.

  7. What is the shelf life of the tablet?
    24–36 months.

  8. Does Taj Pharma export internationally?
    Yes, to over 20 countries worldwide.

  9. Is private labeling available?
    Yes, multilingual labeling and custom branding are offered.

  10. Where is Taj Pharma located?
    Vapi, Gujarat, India.

  11. Is this tablet safe during pregnancy?
    Consult a doctor before use.

  12. What dosage strength is available?
    Cetirizine 5mg + Pseudoephedrine 120mg.

  13. What packaging options are offered?
    Blister packs and bulk packaging.

  14. Does Taj Pharma provide CTD dossiers?
    Yes, CTD/ACTD support is available.

  15. How should the tablet be stored?
    Below 25°C, protected from moisture and light.

  16. Is it suitable for children?
    Only under pediatrician supervision.

  17. What is the global demand?
    High, due to rising allergy and sinus prevalence.

  18. Does Taj Pharma offer PCD Pharma Franchise?
    Yes, PAN India franchise opportunities are available.

  19. Are the tablets extended-release?
    Yes, for sustained action over 12–24 hours.

  20. How can buyers contact Taj Pharma?
    Through official inquiry channels for quotations, samples, and business support.