Description
Levocetirizine Dihydrochloride Tablets (5 mg)
Healthy Inc is a specialized global supplier and exporter of high-affinity H1-receptor antagonists. We provide premium Levocetirizine Dihydrochloride 5 mg Tablets, sourced from WHO–GMP certified solid dosage facilities. As the active R-enantiomer of Cetirizine, this medication is a primary export to pharmacy chains, ENT clinics, and government allergy programs in Africa, LATAM, and Southeast Asia, offering a more potent and faster-acting solution for allergic disorders with reduced sedative potential.
Product Overview
This formulation contains Levocetirizine, a second-generation non-sedating antihistamine that provides 24-hour relief from systemic allergic responses.
The “Enantiopure” Allergy Specialist:
- Mechanism of Action: Levocetirizine is a highly selective and potent antagonist of peripheral H1-receptors. It prevents histamine from binding to its receptors on the surface of cells in the nose, eyes, and skin. By blocking this interaction, it stops the cascade of allergic symptoms such as vasodilation, increased capillary permeability (swelling), and sensory nerve stimulation (itching).
- Superior Potency: Being the pure (R)-enantiomer of Cetirizine, Levocetirizine has a two-fold higher affinity for the H1-receptor than the racemic mixture. This allows for a lower therapeutic dose (5mg) with equivalent or superior efficacy.
- Pharmacokinetic Advantage: It exhibits rapid onset of action (usually within 1 hour) and a sustained 24-hour effect, ensuring once-daily dosing compliance.
Product Composition & Strength
We supply this product as Film Coated Tablets. The small, easy-to-swallow tablets are engineered for rapid disintegration to facilitate quick relief from acute allergic flares.
| Active Ingredient | Strength (Standard) | Therapeutic Role | |
|---|---|---|---|
| Levocetirizine Dihydrochloride BP/USP | 5 mg | Potent H1-Receptor Antagonist | |
| Excipients | Q.S. | Microcrystalline Cellulose / Lactose | Diluent & Disintegrant |
| Coating Agent | Q.S. | Opadry® White | Protective Film Coating |
*Pack Sizes: Alu-Alu Blister packs of 10s (Box of 10×10) or 30s. Calendar packs are available for chronic urticaria management.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Antihistamines – Other) |
| Dosage Form | Tablet (Film Coated) |
| Packaging | Alu-Alu Blister (Cold-form foil for maximum moisture protection) |
| Storage | Store below 30°C. Keep in original packaging to protect from light. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Purity Standards: Our manufacturing process utilizes High-Performance Liquid Chromatography (HPLC) testing to ensure the chiral purity of the R-enantiomer, guaranteeing that no traces of the (S)-enantiomer are present, which minimizes potential side effects.
- Stable Formulation: Levocetirizine can be hygroscopic. We utilize low-moisture excipients and specialized film-coating to ensure the tablet remains stable and effective throughout its shelf life, even in the humid climates of Southeast Asia and Africa.
Therapeutic Indications (Human Use)
Indicated for the symptomatic relief of allergic conditions:
- Allergic Rhinitis: Relief of symptoms associated with seasonal (hay fever) and perennial allergic rhinitis (sneezing, runny nose, itchy nose/palate).
- Ocular Symptoms: Reduction of watery, red, and itchy eyes.
- Chronic Idiopathic Urticaria: Treatment of uncomplicated skin manifestations of chronic hives (itching and wheals).
Dosage & Administration
Recommended Dosage (Strictly as per Physician):
- Route: Oral.
- Adults & Children > 12 years: One 5 mg tablet once daily in the evening.
- Children 6-11 years: 2.5 mg (half tablet) once daily in the evening.
- Administration: Can be taken with or without food. Taking it in the evening is recommended to minimize any potential mild daytime drowsiness.
Safety Warnings:
- Renal Impairment: Dose adjustment is required for patients with impaired kidney function. Contraindicated in end-stage renal disease.
- Drowsiness: While non-sedating for most, some patients may experience mild somnolence. Caution is advised when driving or operating machinery.
- Alcohol: Avoid concurrent use with alcohol as it may further decrease alertness.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for OSD (Oral Solid Dosage) forms, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in











