Phenazopyridine Hydrochloride Tablets (100 mg / 200 mg)
Healthy Inc is a specialized global supplier and exporter of advanced urological, women’s health, and acute-care therapeutics. We provide ultra-high-purity, kinetically stabilized Phenazopyridine Hydrochloride Film-Coated Tablets (100 mg / 200 mg), manufactured in WHO–GMP certified, high-containment dedicated azo-dye isolation facilities. This “Urinary Tract Mucosal Analgesic” is a massive-volume, highly lucrative export to urology centers, gynecology clinics, retail OTC pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally trusted intervention for the rapid, targeted relief of severe pain, burning, and urgency associated with lower urinary tract infections and trauma.
Product Overview
This highly targeted formulation contains Phenazopyridine, a specialized azo dye that is rapidly excreted through the kidneys, allowing it to bathe the inflamed walls of the bladder and urethra in a powerful, localized anesthetic.
The “Urinary Analgesic & UTI Bridge” Specialist:
- Mechanism 1 (The Local Mucosal Anesthetic): Unlike standard painkillers (like Ibuprofen or Paracetamol) that work systemically in the brain or blood, Phenazopyridine exerts a direct, topical analgesic effect purely on the mucosal lining of the urinary tract. As the concentrated dye passes through the bladder and urethra, it rapidly numbs the raw, inflamed tissue, instantly stopping the excruciating burning (dysuria), urgency, and frequency.
- Mechanism 2 (The 48-Hour Antibiotic Bridge): Antibiotics require at least 24 to 48 hours to reduce bacterial loads enough to relieve UTI symptoms. Phenazopyridine is universally prescribed alongside the antibiotic to provide the patient with immediate comfort and massively improve clinical compliance during those first agonizing days of infection.
- Surgical & Catheter Defense: Beyond UTIs, it is heavily utilized by urologists to numb the urinary tract following invasive endoscopic procedures, prostate surgeries, or the traumatic insertion/removal of urinary catheters.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, OTC Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Urologicals/Analgesics) |
| CAS Number | 136-40-3 |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | High-Density PVC/PVDC or Alu-PVC Blisters (STRICTLY MANDATORY). Protects the formulation from environmental humidity across Zone IVb tropical climates. |
| Storage | Store strictly below 25°C in a dry place. Protect from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Dedicated Azo-Dye Containment Engineering (CRITICAL COMPLIANCE): Phenazopyridine is a potent, deep red-orange azo dye. If manufactured in a standard facility, the fine API dust will permanently stain the ventilation systems, compression machines, and cross-contaminate other white tablets (like Paracetamol or Metformin). Our manufacturing occurs in strict, isolated dye-handling suites with dedicated tooling and heavy film-coating pans to completely lock the dye inside the finished tablet, ensuring pristine, cross-contamination-free production.
Therapeutic Indications (Human Use)
Indicated for the targeted, rapid symptomatic relief of urological trauma:
- Dysuria & UTI Symptoms: Symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection.
- Post-Surgical / Catheter Irritation: Relief of mucosal irritation caused by trauma, surgery, endoscopic procedures, or the passage of sounds or catheters.
- CRITICAL LIMITATION: This medication is an analgesic, NOT an antibiotic. It does not treat the underlying bacterial infection.
Dosage & Administration
Recommended Dosage (Strictly as per Urologist/Pharmacist Guidelines):
- Standard Adult Dosing: 200 mg taken orally 3 times daily (TID).
- Administration (THE MEALTIME RULE): To significantly reduce the risk of severe gastric upset and nausea, the tablets MUST be taken after meals. Tablets must be swallowed whole with a full glass of water.
- The 2-Day Limit (CRITICAL PROTOCOL): When used concomitantly with an antibacterial agent for the treatment of a UTI, the administration of Phenazopyridine should not exceed 2 days. Prolonged use will mask the symptoms of a worsening, antibiotic-resistant infection migrating to the kidneys.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Red-Orange Discoloration (Signature Harmless Effect): Patients must be explicitly warned that this medication will turn their urine a bright, glowing red or neon orange color. This is completely harmless but will permanently stain underwear. Furthermore, it can permanently stain soft contact lenses if the patient touches their eyes after handling the tablet.
- Severe Renal Impairment (Absolute Contraindication): Phenazopyridine is heavily excreted by the kidneys. In patients with severe kidney disease or renal failure, the drug will rapidly accumulate to toxic levels in the blood, leading to severe yellowish skin discoloration (jaundice) and systemic toxicity. It is strictly contraindicated in this population.
- Methemoglobinemia & Hemolytic Anemia: Overdosing, or standard dosing in patients with G6PD deficiency, can induce methemoglobinemia (where the blood loses its ability to carry oxygen) and rapid red blood cell destruction (hemolytic anemia).
- Diagnostic Interference: The intense dye in the urine will completely ruin the results of standard colorimetric urinalysis tests (such as dipsticks for ketones, bilirubin, or protein).
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 Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Urological and Women’s Health Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Pharmacy Chain Supplier for OTC UTI relief 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.