Description
Phenazopyridine Hydrochloride Tablets (100 mg / 200 mg)
Healthy Inc is a specialized global supplier and exporter of advanced urological, nephrological, and acute symptomatic therapeutics. We provide ultra-high-purity Phenazopyridine Hydrochloride Tablets (100 mg / 200 mg), manufactured in WHO–GMP certified, strictly segregated oral solid dosage facilities. This “Urinary Tract Mucosal Analgesic” is a massive-volume, essential export to urology centers, emergency departments, retail pharmacy networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally trusted, rapid-onset intervention for the excruciating pain and burning associated with Urinary Tract Infections (UTIs) and urological trauma.
Product Overview
This formulation contains Phenazopyridine Hydrochloride, an azo dye specifically engineered to pass through the digestive system and concentrate in the urine, providing highly targeted, localized pain relief directly to the irritated tissues of the bladder and urethra.
The “Rapid UTI Symptom Reliever” Specialist:
- Mechanism (Topical Mucosal Analgesia): Unlike standard painkillers (like Ibuprofen or Paracetamol) that must circulate systemically, Phenazopyridine works locally. As the kidneys excrete the drug into the urine, the chemical physically bathes the inflamed mucosal lining of the lower urinary tract. This exerts a direct, profound topical analgesic (numbing) effect, instantly stopping the burning, urgency, and frequency associated with cystitis.
- The Antibiotic Bridge: Antibiotics cure the underlying infection, but they take 1 to 2 days to relieve the physical pain. Phenazopyridine bridges this gap, providing immediate comfort so the patient can function normally while waiting for the antibacterial therapy to take effect.
- Crucial Distinction (Not an Antibiotic): It is imperative for clinical networks to understand that Phenazopyridine has absolutely no antibacterial properties. It treats the symptom, not the cause, and must be co-prescribed with an appropriate anti-infective agent (like Co-amoxiclav or Ciprofloxacin).
Product Composition & Strength
We supply this product as a Precision-Blended Film-Coated Tablet, packed in highly secure, moisture-resistant PVC/PVDC or Alu-PVC blister strips to ensure the stability of the active dye compound.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Phenazopyridine Hydrochloride USP/Ph.Eur. | 100 mg | Standard OTC/Initiation dose for mild-to-moderate urinary tract discomfort. |
| Phenazopyridine Hydrochloride USP/Ph.Eur. | 200 mg | Global Prescription Standard: Maximum adult dose for severe dysuria and post-operative catheter trauma. |
| Excipients | Microcrystalline Cellulose / Croscarmellose Sodium / Magnesium Stearate | Diluent / Superdisintegrant (Engineered for rapid gastric dissolution and swift renal clearance) |
*Pack Sizes: 10×10 Blisters (Optimized specifically for short-term, 2-to-3 day acute dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Urology Distributors, and Retail Pharmacy Chains.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Urologicals/Analgesics) |
| CAS Number | 136-40-3 |
| Dosage Form | Film-Coated Tablet (Immediate Release) |
| Packaging | PVC/PVDC or Alu-PVC Blisters. Protects the formulation from environmental humidity across Zone IVb tropical climates. |
| Storage | Store strictly below 25°C in a dry place. 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.
- Dedicated Dye Segregation Protocols: Phenazopyridine is a potent azo dye that intensely stains everything it touches (deep orange/red). Manufacturing this API on standard generic lines risks severe cross-contamination and the rejection of subsequent non-dye product batches. Our facilities utilize strictly dedicated, isolated compression suites and specialized cleaning validation protocols for all dye-based therapeutics, guaranteeing the absolute purity of your entire pharmaceutical portfolio.
Therapeutic Indications (Human Use)
Indicated for the comprehensive, short-term management of acute lower urinary tract symptoms:
- Urinary Tract Irritation: Symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection (UTI), trauma, surgery, endoscopic procedures, or the passage of catheters.
Dosage & Administration
Recommended Dosage (Strictly as per Physician/Urologist Guidelines):
- Standard Adult Dosing: 200 mg taken orally 3 times a day.
- Administration (THE MEALTIME RULE): To significantly reduce the risk of gastrointestinal upset, this medication should be administered with or immediately after meals with a full glass of water.
- The 2-Day Limitation (CRITICAL FOR UTIs): When used concurrently with an antibacterial agent for the treatment of a UTI, the administration of Phenazopyridine should not exceed 2 days. Prolonged use risks masking the symptoms of an antibiotic-resistant infection, preventing the physician from knowing if the antibacterial therapy has failed.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Urine Discoloration (Mandatory Patient Counseling): The drug produces a reddish-orange discoloration of the urine and feces. This is a harmless, expected effect, but patients must be explicitly warned to prevent severe panic (as it mimics hematuria/blood in the urine). It will permanently stain undergarments and soft contact lenses.
- G6PD Deficiency (Hemolytic Anemia Risk): It is strictly contraindicated in patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency. In these patients, the drug triggers a catastrophic breakdown of red blood cells (hemolytic anemia).
- Renal Impairment: Because the drug is entirely cleared by the kidneys, it is contraindicated in patients with significant renal impairment or severe hepatitis. Accumulation of the drug can lead to yellowish discoloration of the skin and sclera (eyes), indicating toxicity.
- Methemoglobinemia: Overdosing can cause methemoglobinemia (a blood disorder where oxygen is not effectively delivered to tissues), presenting as bluish skin (cyanosis) and shortness of breath.
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 Analgesic Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Pharmacy Chain Supplier 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.








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