Hydroxyzine HCl Tablets USP 10mg
Hydroxyzine HCl Tablets USP 25mg
Hydroxyzine HCl Tablets USP 50mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Hydroxyzine HCl Tablets USP 10mg
Each film coated Tablet contains:
Hydroxyzine Hydrochloride USP…………...10mg
Excipients……………………………………... q. s
Colours: Titanium Dioxide BP
b) Hydroxyzine HCl Tablets USP 25mg
Each film coated Tablet contains:
Hydroxyzine Hydrochloride USP…………….25mg
Excipients………………………………………. q.s
Colours: Carmoisine Lake
c) Hydroxyzine HCl Tablets USP 50mg
Each film coated Tablet contains:
Hydroxyzine Hydrochloride USP…………….50mg
Excipients………………………………………. q.s
Colours: Red Iron Oxide
Each film coated Tablet contains:
Hydroxyzine Hydrochloride USP…………...10mg
Excipients……………………………………... q. s
Colours: Titanium Dioxide BP
b) Hydroxyzine HCl Tablets USP 25mg
Each film coated Tablet contains:
Hydroxyzine Hydrochloride USP…………….25mg
Excipients………………………………………. q.s
Colours: Carmoisine Lake
c) Hydroxyzine HCl Tablets USP 50mg
Each film coated Tablet contains:
Hydroxyzine Hydrochloride USP…………….50mg
Excipients………………………………………. q.s
Colours: Red Iron Oxide
THERAPEUTIC INDICATIONS:
Hydroxyzine Hydrochloride is indicated to assist in the management of anxiety in adults. Hydroxyzine Hydrochloride is indicated for the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and atopic and contact dermatitis in adults and children.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
*Not suitable for children under 12 years.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
*Not suitable for children under 12 years.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
STORAGE & DOSAGE:
Storage: Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).
Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature].
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature].
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Hydroxyzine HCl Tablets USP 10mg Technical Specification:
| Product Name: | Hydroxyzine HCl Tablets USP 10mg |
| Brand Name: | Generic |
| Strength: | 10mg, 25mg, 50mg |
| Dosage Form: | Tablet (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 100s, 500s, 1000s |
| 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-allergic, Antihistamine |
| Indication: | Hydroxyzine is used to treat itching caused by allergies. It is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Hydroxyzine may also be used short-term to treat anxiety or to help you feel sleepy/relaxed before and after surgery. |
| Storage: | Store at 20° to 25° C (68° to 77° F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Hydroxyzine HCl Tablets USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Hydroxyzine HCl Tablets USP 10mg
Each film coated Tablet contains:
Hydroxyzine Hydrochloride USP……………10mg
Excipients……………………………………… q. s
Colours: Titanium Dioxide BP
THERAPEUTIC INDICATIONS:
Hydroxyzine Hydrochloride is indicated to assist in the management of anxiety in adults. Hydroxyzine Hydrochloride is indicated for the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and atopic and contact dermatitis in adults and children.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Not suitable for children under 12 years.
Read enclosed leaflet before use.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).
Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature].
Dosage: As directed by the Physician.
Hydroxyzine HCl Tablets USP 10mg Manufacturer Supplier in India
Introduction to Hydroxyzine HCl Tablets USP 10mg
The global pharmaceutical industry continues to witness increasing demand for high-quality antihistamine and anxiolytic medications. Among the most prescribed medicines in this category is Hydroxyzine HCl Tablets USP 10mg, a trusted medication used worldwide for managing allergic conditions, anxiety disorders, and preoperative sedation. As healthcare systems expand across developed and emerging markets, demand for reliable suppliers and exporters of Hydroxyzine HCl Tablets USP 10mg has significantly increased.
Taj Pharma, a well-known Hydroxyzine HCl Tablets USP 10mg Manufacturer in India, provides assurance of superior quality, purity, safety, and international compliance standards. The company has established itself as a trusted pharmaceutical manufacturer, exporter, and supplier serving healthcare organizations, distributors, hospitals, government tenders, and importers globally.
Hydroxyzine HCl Tablets USP 10mg are prescription-only antihistamine medicines primarily used to:
- Relieve mild-to-moderate anxiety
- Control itching associated with allergic skin conditions
- Treat urticaria (hives)
- Manage dermatitis-related itching
- Provide sedation before and after medical procedures
- Support symptomatic relief in allergic reactions
As a leading Hydroxyzine HCl Tablets USP 10mg Supplier, Taj Pharma ensures consistent product quality through stringent manufacturing practices and advanced quality control systems.
About Hydroxyzine HCl Tablets USP 10mg
Hydroxyzine is an antihistaminic medication that works by blocking the action of histamine, a naturally occurring chemical messenger responsible for allergy symptoms.
In allergic conditions, Hydroxyzine helps relieve:
- Itching
- Skin rashes
- Swelling
- Redness
- Allergic reactions
In anxiety disorders, Hydroxyzine decreases activity in specific areas of the brain, helping patients feel calm, relaxed, and less anxious.
Benefits of Hydroxyzine HCl Tablets USP 10mg
- Fast relief from allergy symptoms
- Effective management of mild anxiety
- Non-addictive alternative for short-term anxiety treatment
- Helps improve sleep quality
- Suitable for preoperative sedation
Hydroxyzine HCl Tablets USP 10mg Manufacturer in India
Taj Pharma Ltd is a top-known Manufacturer, Exporter, and Supplier of Hydroxyzine HCl Tablets USP 10mg from Vapi, Gujarat, India. The company has earned global recognition for delivering affordable, high-quality pharmaceutical products that comply with international standards.
Being a trusted WHO-GMP Manufacturer India, Taj Pharma provides comprehensive pharmaceutical solutions including:
- Contract Manufacturing
- Third Party Manufacturing
- Private Label Manufacturing
- PCD Pharma Franchise Support
- International Export Services
- Regulatory Documentation Assistance
The company’s manufacturing facilities utilize advanced production technology and stringent quality assurance systems to ensure every batch meets international pharmacopoeial requirements.
Why Global Buyers Choose Taj Pharma
State-of-the-Art Manufacturing Facility
Taj Pharma operates modern manufacturing facilities equipped with advanced pharmaceutical technology and automated production systems. Every production stage follows strict quality standards ensuring consistency and compliance.
International Quality Standards
The company adheres to:
- WHO-GMP Guidelines
- Good Manufacturing Practices (GMP)
- Quality Assurance Protocols
- Pharmacovigilance Systems
- Regulatory Compliance Standards
Affordable Pricing
One of the key advantages of sourcing from India is cost efficiency. Taj Pharma offers competitive pricing without compromising product quality, making it a preferred partner for international importers and distributors.
Global Export Expertise
With extensive export experience, Taj Pharma supports:
- Product Registration
- Regulatory Filing
- Documentation Support
- Logistics Management
- Customs Clearance Assistance
Reliable Supply Chain
The company maintains efficient inventory management systems ensuring uninterrupted supply to international customers.
Regulatory Documentation Available for Importers
Global pharmaceutical buyers require complete documentation for successful product registration and importation.
Taj Pharma provides:
Export Documentation
- Certificate of Pharmaceutical Product (COPP)
- Certificate of Analysis (COA)
- Certificate of Origin
- Free Sale Certificate
- Manufacturing License
- Product Permission
- Batch Manufacturing Records
Regulatory Dossiers
- CTD Dossier
- ACTD Dossier
- eCTD Documentation
- Stability Studies
- Bioequivalence Data (where applicable)
- Validation Reports
Quality Documentation
- WHO-GMP Certificate
- EU-GMP Support Documentation
- ISO Certifications
- Product Specifications
- Analytical Method Validation
Custom Packaging and Labeling Services
Taj Pharma understands diverse international market requirements.
The company offers:
- Customized carton designs
- Private labeling solutions
- Country-specific labeling
- Multilingual packaging
- Hospital packaging
- Tender packaging
- Distributor branding solutions
Packaging formats include:
- Blister Packs
- Alu-Alu Packaging
- Strip Packaging
- Bulk Packaging
- Export Packaging
Shelf Life, Storage and Dosage Information
Dosage Form
Tablet
Strength
Hydroxyzine HCl USP 10mg
Shelf Life
24 to 36 Months (depending upon registration requirements)
Storage Conditions
Store below 25°C in a cool, dry place away from direct sunlight and moisture.
Route of Administration
Oral
Export Certifications
Taj Pharma supports international business through comprehensive certifications including:
- WHO-GMP Certification
- COPP Certification
- CTD Dossier
- ACTD Dossier
- Product Registration Support
- Stability Data
- Export License
- Manufacturing License
- Free Sale Certificate
These certifications simplify product registration and import approval processes across international markets.
Target Export Markets
Taj Pharma exports Hydroxyzine HCl Tablets USP 10mg to multiple regulated and semi-regulated markets.
Major Export Regions
- Africa
- Asia
- CIS Countries
- Latin America
- Middle East
- Southeast Asia
Top 20 Countries Exporting
United States | United Kingdom | Germany | France | South Africa | Nigeria | Kenya | Ghana | Ethiopia | Tanzania | Uganda | Philippines | Vietnam | Cambodia | Myanmar | Sri Lanka | Nepal | Yemen | Iraq | UAE
Technical Product Specification Table
| Parameter | Specification |
|---|---|
| Product Name | Hydroxyzine HCl Tablets USP 10mg |
| Generic Name | Hydroxyzine Hydrochloride |
| Strength | 10mg |
| Dosage Form | Tablet |
| Pharmacological Class | Antihistamine |
| Therapeutic Use | Allergy & Anxiety Management |
| Route of Administration | Oral |
| Packaging | Blister / Alu-Alu |
| Shelf Life | 24-36 Months |
| Storage | Below 25°C |
| Regulatory Status | Prescription Medicine |
| Manufacturer | Taj Pharma Ltd |
| Manufacturing Location | Vapi, Gujarat, India |
| Export Availability | Worldwide |
| GMP Compliance | WHO-GMP |
Safety Information and Side Effects
Most side effects do not require medical attention and disappear as the body adjusts to the medication.
Common Side Effects
- Sedation
- Nausea
- Vomiting
- Upset Stomach
- Constipation
- Drowsiness
Patients should consult their healthcare provider if side effects persist or worsen.
Important Precautions
You have been prescribed Hydroxyzine to treat allergy symptoms such as itching, swelling, and rashes or to relieve mild anxiety.
- May decrease alertness.
- Avoid driving if drowsiness occurs.
- Avoid operating heavy machinery.
- Avoid alcohol consumption.
- Follow the prescribed dosage.
- Do not skip doses.
Hydroxyzine HCl Tablets USP 10mg is safe when used according to physician recommendations.
Top 20 FAQs
1. What is Hydroxyzine HCl Tablets USP 10mg used for?
It is used for allergies, itching, anxiety, and sedation.
2. Is Hydroxyzine prescription-only?
Yes, it should be used under medical supervision.
3. Who is the leading Hydroxyzine HCl Tablets USP 10mg Manufacturer in India?
Taj Pharma is among the leading manufacturers and exporters.
4. Can Hydroxyzine cause drowsiness?
Yes, drowsiness is a common side effect.
5. Is Hydroxyzine safe?
Yes, when used as prescribed by a healthcare professional.
6. Does Taj Pharma export worldwide?
Yes, Taj Pharma exports to numerous international markets.
7. What certifications are available?
WHO-GMP, COPP, CTD Dossier, and related documentation.
8. Can importers receive custom packaging?
Yes, customized packaging is available.
9. What is the shelf life?
Generally 24–36 months.
10. Is private labeling available?
Yes.
11. Does Taj Pharma support product registration?
Yes.
12. Is Hydroxyzine used for anxiety?
Yes, for short-term anxiety management.
13. What packaging options are available?
Blister, Alu-Alu, and bulk packaging.
14. Is export documentation provided?
Yes, complete export documentation is supplied.
15. Can distributors partner with Taj Pharma?
Yes.
16. Is PCD Pharma Franchise available?
Yes.
17. Does Hydroxyzine treat skin allergies?
Yes.
18. What storage conditions are recommended?
Store below 25°C.
19. Can alcohol be consumed with Hydroxyzine?
No, alcohol should be avoided.
20. How can buyers contact Taj Pharma?
Contact details are listed below.
Contact Taj Pharma for Global Supply
Whether you are an importer, distributor, wholesaler, government procurement agency, hospital group, pharmacy chain, or pharmaceutical company, Taj Pharma offers reliable solutions for Hydroxyzine HCl Tablets USP 10mg export from India.
WhatsApp Support:
+91 – 74 0000 9975
+91 – 74 0000 9976
Email:
