Description
Cetirizine Tablets (5mg / 10mg)
Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc
1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Cetirizine Tablets in India. This second-generation antihistamine is the global first-line treatment for Seasonal Allergic Rhinitis (Hay Fever) and Chronic Urticaria (Hives). We produce high-purity Cetirizine Hydrochloride tablets that provide rapid, non-sedating relief for up to 24 hours. Our facility adheres to strict WHO-GMP standards. Healthy Inc manages our global exports and pharmacy tenders.
2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Cetirizine Tablets | | Generic Name | Cetirizine Hydrochloride USP / BP / IP | | Strength | 5mg / 10mg | | Dosage Form | Film Coated Tablet / Dispersible Tablet (DT) | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Antihistamine (H1 Receptor Antagonist) | | Shelf Life | 36 Months | | Packaging | 10×10 Blister / 10×15 Strip / 1000s Bulk Jar |
3. Manufacturing Cetirizine Tablets We divide our operations to ensure specialized focus.
The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Cetirizine API is intensely bitter. To ensure patient comfort, we apply a high-quality Polymer Film Coating that completely masks the taste and makes the tablet easy to swallow. We also use Rapid-Release Granulation, ensuring the tablet disintegrates quickly in the stomach so the patient feels relief within 20–60 minutes of ingestion.
The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Cetirizine Tablets. We supply retail pharmacy chains and supermarkets globally. We offer attractive “OTC-Style” packaging designs for private label clients who sell directly to consumers.
4. Quality Assurance We test every batch rigorously.
Dissolution: We test how fast the tablet releases the drug. Fast release is critical for an allergy medication where patients want immediate relief.
Impurity Profiling: We strictly monitor for related substances to ensure the drug remains stable and safe over its 3-year shelf life.
Assay: We confirm the 10mg potency to ensure 24-hour efficacy.
5. Why Use Cetirizine Tablets? This drug blocks the effects of histamine without causing severe drowsiness.
Mechanism: It selectively binds to peripheral H1 histamine receptors. This stops histamine from causing symptoms like itching, sneezing, and swelling.
Effect: It relieves runny nose, watery eyes, sneezing, and itchy skin rashes. Unlike older antihistamines (like Chlorpheniramine), it causes significantly less sedation.
Key Indications:
Allergic Rhinitis: Seasonal (Hay Fever) and Perennial (Dust Mites/Pet Dander).
Chronic Urticaria: Relief of itching and reduction of hives (wheals) in chronic skin allergies.
Allergic Conjunctivitis: Relief of itchy, watery eyes.
6. Export and Regulatory Support We provide complete documentation for registration.
Dossier: We offer CTD and ACTD formats.
Certificates: We supply the Free Sale Certificate (FSC) and COPP.
Logistics: We ship via FOB Mumbai or CIF.
7. Frequently Asked Questions
Q: Who manufactures Cetirizine Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
Q: Does this make you sleepy? A: Cetirizine is classified as “non-sedating,” but some sensitive individuals may experience mild drowsiness. It is much less sedating than older drugs.
Q: Do you have a scored tablet? A: Yes, our 10mg tablets often have a break-line so they can be split into 5mg doses for children (6-12 years).
CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Adults & Children > 12 years: 10mg once daily.
Children 6-12 years: 5mg twice daily (or 10mg once daily).
Administration: Swallow with liquid. Can be taken with or without food.
9. Side Effects and Precautions
Common Side Effects: Mild drowsiness, dry mouth, and fatigue.
Renal Impairment: Dosage must be reduced in patients with kidney disease.
Alcohol: Avoid alcohol while taking this medication as it may increase drowsiness.
10. Storage Instructions
Store below 25°C in a dry place.
Protect from light.
Keep out of reach of children.
