GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Loratadine and Pseudoephedrine Sulphate Tablet USP (5mg+120mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Un-coated tablet contains:
Loratadine USP.………………………….….…..….10mg
Pseudoephedrine Sulphate USP …………….240mg
B) Loratadine and Pseudoephedrine Sulphate Tablet USP (5mg+120mg)
Each Un-coated tablet contains:
Loratadine USP.………………………….….…..….5mg
Pseudoephedrine Sulphate USP …………….120mg
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
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:
Dosage: As directed by the Physician
Attach dispensing label as per end county.
Loratadine and Pseudoephedrine Sulphate Tablet (5mg+120mg) Technical Specification:
| Product Name: | Loratadine and Pseudoephedrine Sulphate Tablet USP |
| Brand Name: | Generic |
| Strength: | (10mg+240mg), (5mg+120mg) |
| Dosage Form: | Tablets (Un-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 20s, 30s, 50s, 100s |
| 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: | Loratadine is an antihistamine which provides relief of seasonal allergy symptoms such as watery and itching eyes, runny nose, and sneezing. Pseudoephedrine is a decongestant which helps relieve a stuffy nose, promotes sinus draining, and improves breathing. |
| Storage: | Store at 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Loratadine and Pseudoephedrine Sulphate Tablet USP (10mg+240mg)
- Loratadine and Pseudoephedrine Sulphate Tablet USP (5mg+120mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Loratadine and Pseudoephedrine Sulphate Tablet USP (10mg+240mg)
Each Un-coated tablet contains:
Loratadine USP.………………………….….…..….10mg
Pseudoephedrine Sulphate USP …………….240mg - Loratadine and Pseudoephedrine Sulphate Tablet USP (5mg+120mg)
Each Un-coated tablet contains:
Loratadine USP.………………………….….…..….5mg
Pseudoephedrine Sulphate USP …………….120mg
THERAPEUTIC INDICATIONS:
- Loratadine is an antihistamine which provides relief of seasonal allergy symptoms such as watery and itching eyes, runny nose, and sneezing. Pseudoephedrine is a decongestant which helps relieve a stuffy nose, promotes sinus draining, and improves breathing.
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 Loratadine and Pseudoephedrine Sulphate Tablet (5mg+120mg)
What It Is
This combination medicine contains:
-
Loratadine (5mg): A second-generation antihistamine that relieves allergy symptoms without causing significant drowsiness.
-
Pseudoephedrine Sulphate (120mg): A nasal decongestant that reduces swelling in nasal passages, easing breathing.
Together, they provide 12-hour sustained relief from sneezing, runny nose, nasal congestion, and other allergy or cold-related symptoms.
Uses and Benefits
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Treats seasonal and perennial allergic rhinitis
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Reduces nasal congestion and sinus pressure
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Provides 12-hour symptom control
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Improves quality of life for allergy sufferers
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Over-the-counter availability increases accessibility
Global Demand
With a rise in air pollution, environmental allergens, and seasonal allergies, the global demand for combination allergy medications like Loratadine and Pseudoephedrine Sulphate Tablet (5mg+120mg) has surged. Countries in Africa, Asia, the Middle East, and Latin America depend on high-quality Indian manufacturers like Taj Pharma for consistent, WHO-GMP certified supplies.
In-Depth Details for Importers, Exporters & Buyers
Taj Pharma offers comprehensive support for international buyers, ensuring regulatory compliance, packaging customization, and reliable delivery.
Regulatory Documentation Provided
For hassle-free imports, Taj Pharma provides:
-
WHO-GMP Certification
-
ISO 9001:2015 Certification
-
Certificate of Pharmaceutical Product (COPP)
-
CTD/ACTD dossiers for international registration
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Batch-specific Certificate of Analysis (COA)
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Free Sale Certificate (FSC)
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Manufacturing license & MSDS
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Stability reports (real-time and accelerated)
Custom Packaging & Labeling
Taj Pharma supports international buyers with flexible packaging options:
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Blister packs (Alu-Alu) for moisture protection
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HDPE bottles for bulk distribution
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Private labeling and OEM branding
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Multilingual labels for global compliance
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Tamper-proof, high-barrier packaging
This ensures the product meets the regulatory standards of importing countries.
Shelf-Life, Storage & Dosage Form
| Parameter | Specification |
|---|---|
| Dosage Form | Extended-release tablet |
| Strength | Loratadine 5mg + Pseudoephedrine Sulphate 120mg |
| Shelf-life | 24–36 months |
| Storage Conditions | Store below 25°C, protect from moisture and sunlight |
| Packaging | Alu-Alu blister, HDPE bottles |
| Administration | Oral, 12-hour dosing |
| OTC Status | Available as per regional regulations |
Export Certifications Offered
All exports from Taj Pharma comply with globally recognized certifications:
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WHO-GMP certified facilities
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EU-GMP compliant manufacturing
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ISO 9001:2015
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COPP & FSC for international trade
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GLP-compliant stability studies
-
Batch-specific COAs
-
CTD/ACTD dossiers for registration in target countries
Target Countries & Export Markets
Taj Pharma exports Loratadine and Pseudoephedrine Sulphate Tablet (5mg+120mg) to over 40 countries including:
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Nigeria
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Kenya
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Tanzania
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Uganda
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South Africa
-
Ghana
-
UAE
-
Saudi Arabia
-
Iraq
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Yemen
-
Vietnam
-
Cambodia
-
Philippines
-
Nepal
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Sri Lanka
-
Russia
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Kazakhstan
-
Bolivia
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Peru
-
Chile
Why Taj Pharma is the Most Trusted Manufacturer & Exporter
1. State-of-the-Art Manufacturing
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Modern WHO-GMP certified production facilities
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Advanced automated tablet compression and coating machines
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State-of-the-art quality control and analytical labs
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Environmental and quality monitoring systems
2. Affordable Pricing & Quality Assurance
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Competitive bulk export pricing
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High-quality tablets without compromising safety
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PCD Pharma franchise & private labeling opportunities
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Regulatory compliance for all global markets
3. Global Supply Chain & Support
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Temperature-controlled logistics for sensitive medications
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Fast turnaround for international orders
-
Comprehensive documentation support
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Custom solutions for distributors, wholesalers, and PCD Pharma partners
4. Top 20 Export Countries
USA, UK, South Africa, Kenya, Nigeria, Ghana, Vietnam, Myanmar, Philippines, Bangladesh, Sri Lanka, Iraq, Yemen, Uzbekistan, Kazakhstan, Georgia, Peru, Bolivia, Ukraine, Cambodia
Technical Product Specification Table
| Attribute | Specification |
|---|---|
| Brand Name | Loratadine and Pseudoephedrine Sulphate Tablet |
| Strength | 5mg + 120mg |
| Manufacturer | Taj Pharma, India |
| Dosage Form | Extended-release tablet |
| Therapeutic Class | Antihistamine + Decongestant |
| Indication | Allergic rhinitis, common cold |
| Packaging | Alu-Alu blister, HDPE bottle |
| Shelf-life | 24–36 months |
| Certifications | WHO-GMP, ISO, GLP |
| MOQ | As per buyer requirement |
| Export Support | CTD/ACTD dossier, FSC, COPP, COA |
Call to Action
For a reliable Loratadine and Pseudoephedrine Sulphate Tablet (5mg+120mg) Manufacturer & Supplier in India, Taj Pharma is your ideal partner.
We provide:
-
Bulk export orders
-
Private label production
-
PCD Pharma franchise opportunities
-
Government tenders and global supply
-
Complete regulatory and documentation support
📧 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com
📍 Location: Vapi, Gujarat, India
Top 20 FAQs
1. What is the tablet used for?
Relief from allergy symptoms such as sneezing, runny nose, and nasal congestion.
2. Who is the leading manufacturer in India?
Taj Pharma, WHO-GMP certified.
3. How does it work?
Loratadine relieves allergy symptoms; pseudoephedrine reduces nasal congestion.
4. Is Taj Pharma WHO-GMP approved?
Yes, along with ISO and GLP certifications.
5. Packaging options?
Alu-Alu blister packs and HDPE bottles.
6. Shelf life?
24–36 months.
7. Regulatory dossiers provided?
Full CTD/ACTD dossiers available.
8. Private labeling available?
Yes, OEM production is offered.
9. Common side effects?
Dry mouth, headache, nausea, restlessness, drowsiness, tiredness.
10. Safe for children?
Use only as per pediatrician guidance.
11. Export markets?
40+ countries including Africa, Asia, Middle East, and Latin America.
12. COA availability?
Yes, for each batch.
13. Recommended dosage?
As prescribed by healthcare professionals.
14. Suitable for government tenders?
Yes, widely supplied for tenders globally.
15. Moisture-resistant packaging?
Yes, Alu-Alu and HDPE packaging available.
16. Monopoly rights for distributors?
Yes, under PCD Pharma franchise.
17. Stability studies?
Real-time and accelerated stability studies available.
18. Shipping timelines?
7–15 business days for international shipments.
19. Sample availability?
Yes, for registered buyers.
20. Why choose Taj Pharma?
Superior quality, global compliance, affordable pricing, and reliable supply chain support.






