Description
Promethazine Hydrochloride Tablets
Healthy Inc is a specialized global supplier and exporter of multi-purpose phenothiazine derivatives. We provide high-purity Promethazine Hydrochloride Tablets, sourced from WHO–GMP certified solid dosage facilities. This “First-Generation” antihistamine is a top export to travel medicine clinics, surgical wards, and pharmacy chains in Africa, LATAM, and Southeast Asia, serving as a versatile agent for the management of severe allergies, motion sickness, and short-term sedation.
[Image of Promethazine mechanism blocking Histamine H1 receptors in the brain and periphery]
Product Overview
This formulation contains Promethazine Hydrochloride, a phenothiazine with potent antihistaminic, antiemetic, and sedative properties.
The “Triple-Action” Specialist:
- Mechanism (Antihistamine): It competitively blocks H1-receptors, preventing the action of histamine. This reduces the symptoms of allergic reactions (itching, swelling, runny nose). Unlike modern antihistamines, it crosses the blood-brain barrier easily, leading to sedation.
- Mechanism (Antiemetic): It exerts an anti-nausea effect by blocking dopamine D2 receptors in the Chemoreceptor Trigger Zone (CTZ) of the brain and inhibiting histamine signals from the inner ear (vestibular apparatus), making it highly effective for motion sickness.
- Mechanism (Sedative): Due to its strong central anticholinergic and H1-blocking activity, it induces calmness and sleep, often used for pre-operative sedation.
Product Composition & Strength
We supply this product as Sugar Coated Tablets (Blue/White) or Film Coated Tablets. The coating is critical to mask the numbing anesthetic effect the drug has on the tongue and to protect the light-sensitive core.
| Active Ingredient | Strength (Standard) | Primary Role |
|---|---|---|
| Promethazine HCl USP/BP | 10 mg | Pediatric (Older) / Allergy |
| Promethazine HCl USP/BP | 25 mg | Sedation / Motion Sickness |
| Excipients | Q.S. | Lactose / Sucrose (Coating) |
*Pack Sizes: Blister packs of 10s (Box of 10×10), 50s, 100s, or Bulk HDPE Jars.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Tablet (Coated) |
| Packaging | PVC-Alu Blister or Alu-Alu Blister (Light Sensitive) |
| Storage | Store below 25°C. Protect from Light (Turns Blue/Pink if oxidized). |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Photostability Engineering: Promethazine is chemically a phenothiazine, which oxidizes rapidly when exposed to light or moisture, turning the tablet blue or pink. We use opaque blisters and a robust sugar-coating barrier to ensure the tablet remains white and potent until the expiration date.
- Taste & Numbing Masking: The raw API has a strong bitter taste and a local anesthetic effect (numbs the mouth). Our coating process ensures the patient swallows the tablet intact without experiencing these unpleasant sensations.
Therapeutic Indications (Human Use)
Indicated for the management of allergic conditions and nausea:
- Allergic Conditions: Perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis, and urticaria (hives).
- Motion Sickness: Prevention and treatment of nausea, vomiting, and dizziness associated with travel.
- Sedation: Pre-operative and post-operative sedation; adjunct to analgesics for control of post-operative pain.
- Nausea & Vomiting: Post-operative nausea or gastroenteritis-induced vomiting.
Dosage & Administration
Recommended Dosage (Strictly as per Physician):
- Route: Oral.
- Allergy: 25 mg taken at bedtime (or 12.5 mg taken before meals and at bedtime).
- Motion Sickness: 25 mg taken 30 to 60 minutes before travel. Repeat after 8-12 hours if needed.
- Sedation (Adults): 25 mg to 50 mg at bedtime.
- Administration: Take with food, water, or milk to minimize gastric irritation.
Safety Warnings:
- Respiratory Depression (FATAL IN CHILDREN): BLACK BOX WARNING: Promethazine is CONTRAINDICATED in children under 2 years of age due to the risk of fatal respiratory depression (stopping breathing). Use caution in children 2 years and older.
- Sedation: Causes significant drowsiness. Do not drive or operate heavy machinery.
- Anticholinergic Effects: Dry mouth, blurred vision, urinary retention, and constipation.
- Photosensitivity: Can make skin sensitive to sunlight. Avoid prolonged sun exposure.
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
