Phenazopyridine Hydrochloride
Phenazopyridine · Tablet · Oral
Uses
Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days (see DOSAGE AND ADMINISTRATION section).
Dosage and administration
100 mg Tablets: Average adult dosage is two tablets 3 times a day after meals. 200 mg Tablets: Average adult dosage is one tablet 3 times a day after meals. When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Phenazopyridine HCl should not exceed 2 days.
Contraindications
Phenazopyridine HCl should not be used in patients who have previously exhibited hypersensitivity to it. The use of Phenazopyridine HCl is contraindicated in patients with renal insufficiency.
Precautions
General A yellowish tinge of the skin or sclera may indicate accumulation due to impaired renal excretion and the need to discontinue therapy. The decline in renal function associated with advanced age should be kept in mind. NOTE: Patients should be informed that Phenazopyridine HCl produces a reddish-orange discoloration of the urine and may stain fabric. Staining of contact lenses has been reported. Laboratory Test Interaction Due to its properties as an azo dye, Phenazopyridine HCl may interfere with urinalysis based on spectrometry or color reactions. Carcinogenicity, Mutagenicity, Impairment of Fertility Long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted. Pregnancy Reproduction studies have been performed in rats at doses up to 50 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to Phenazopyridine HCl. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers No information is available on the appearance of Phenazopyridine HCl, or its metabolites in human milk.
Side effects
Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see OVERDOSAGE section). To report SUSPECTED ADVERSE REACTIONS, contact Allucent at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Pregnancy
Pregnancy Reproduction studies have been performed in rats at doses up to 50 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to Phenazopyridine HCl. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Overdosage
Exceeding the recommended dose in patients with good renal function or administering the usual dose to patients with impaired renal function (common in elderly patients) may lead to increased serum levels and toxic reactions. Methemoglobinemia generally follows a massive, acute overdose. Methylene blue, 1 to 2 mg/kg/body weight intravenously or ascorbic acid 100 to 200 mg given orally should cause prompt reduction of the methemoglobinemia and disappearance of the cyanosis which is an aid in diagnosis. Oxidative Heinz body hemolytic anemia may also occur, and "bite cells" (degmacytes) may be present in a chronic overdosage situation. Red blood cell G-6-PD deficiency may predispose to hemolysis. Renal and hepatic impairment and occasional failure, usually due to hypersensitivity, may also occur.
Description
Phenazopyridine Hydrochloride, USP is light or dark red to dark violet, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. It has the following structural formula: C 11 H 11 N 5 ∙HCl M.W. 249.70 Phenazopyridine HCl tablets, USP contain the following inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch. Chemical Structure
How supplied
Phenazopyridine HCl tablets, USP 100 mg are available as deep brown to maroon colored, round, film-coated tablets debossed "PY" above "1" on one side and plain on the other. Bottles of 100 NDC 64950-550-01 Phenazopyridine HCl tablets, USP 200 mg are available as deep brown to maroon colored, round, film-coated tablets debossed "PY" above "2" on one side and plain on the other. Bottles of 100 NDC 64950-551-01 DISPENSE contents with a child-resistant closure (as required) and in a tight container as defined in the USP. STORE at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Storage
DISPENSE contents with a child-resistant closure (as required) and in a tight container as defined in the USP. STORE at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Label text from the FDA structured product label by Genus Lifesciences Inc. (revised Jul 14, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Phenazopyridine Hydrochloride in 48 products
Phenazopyridine Hydrochloride NDC products (48)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-5904 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | A-S Medication Solutions | UNAPPROVED DRUG OTHER |
| 50090-6442 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | A-S Medication Solutions | UNAPPROVED DRUG OTHER |
| 50090-6951 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | A-S Medication Solutions | UNAPPROVED DRUG OTHER |
| 50090-6952 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | A-S Medication Solutions | UNAPPROVED DRUG OTHER |
| 50090-7291 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | A-S Medication Solutions | UNAPPROVED DRUG OTHER |
| 50090-5876 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | A-S Medication Solutions | UNAPPROVED DRUG OTHER |
| 65162-682 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | Amneal Pharmaceuticals LLC | UNAPPROVED DRUG OTHER |
| 65162-681 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | Amneal Pharmaceuticals LLC | UNAPPROVED DRUG OTHER |
| 71335-2321 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 71335-2323 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 71335-2750 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 71335-9712 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 72162-2540 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 62135-403 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER |
| 62135-404 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER |
| 64950-551 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | Genus Lifesciences Inc. | UNAPPROVED DRUG OTHER |
| 64950-550 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | Genus Lifesciences Inc. | UNAPPROVED DRUG OTHER |
| 50696-003 | Phenazopyridine Hydrochloride 99.5 mg/1 Tablet | GPT Pharmaceuticals Private Limited | UNAPPROVED DRUG OTHER |
| 51655-007 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | Northwind Health Company, LLC | UNAPPROVED DRUG OTHER |
| 51655-424 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | Northwind Health Company, LLC | UNAPPROVED DRUG OTHER |
| 68071-5302 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER |
| 68071-5309 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER |
| 68071-2273 | Phenazopyridine Hydrochloride 95 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | UNAPPROVED DRUG OTHER |
| 68071-2357 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | UNAPPROVED DRUG OTHER |
| 68071-2479 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | UNAPPROVED DRUG OTHER |
| 72789-362 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER |
| 72789-288 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER |
| 68788-8695 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | Preferred Pharmaceuticals Inc | UNAPPROVED DRUG OTHER |
| 68788-8668 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | Preferred Pharmaceuticals Inc. | UNAPPROVED DRUG OTHER |
| 68788-7981 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | Preferred Pharmaceuticals Inc. | UNAPPROVED DRUG OTHER |
| 68788-7902 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | Preferred Pharmaceuticals Inc. | UNAPPROVED DRUG OTHER |
| 82804-995 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER |
| 82804-994 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER |
| 82804-192 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER |
| 71205-813 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER |
| 82804-125 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER |
| 82804-047 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER |
| 67296-2206 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | Redpharm Drug | UNAPPROVED DRUG OTHER |
| 70518-3868 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | REMEDYREPACK INC. | UNAPPROVED DRUG OTHER |
| 70518-0218 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | REMEDYREPACK INC. | UNAPPROVED DRUG OTHER |
| 70518-3986 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | REMEDYREPACK INC. | UNAPPROVED DRUG OTHER |
| 70518-3975 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | REMEDYREPACK INC. | UNAPPROVED DRUG OTHER |
| 70518-3443 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | REMEDYREPACK INC. | UNAPPROVED DRUG OTHER |
| 83939-0021 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | VERITYRX, LLC | UNAPPROVED DRUG OTHER |
| 69367-611 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 69367-612 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 75826-114 | Phenazopyridine Hydrochloride 100 mg/1 Tablet | Winder Laboratories, LLC | UNAPPROVED DRUG OTHER |
| 75826-115 | Phenazopyridine Hydrochloride 200 mg/1 Tablet | Winder Laboratories, LLC | UNAPPROVED DRUG OTHER |
Phenazopyridine Hydrochloride recalls
- D-0545-2024 Jun 19, 2024 · Class II · Completed
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Frequently asked questions
What is Phenazopyridine Hydrochloride used for?
Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative…
What are the side effects of Phenazopyridine Hydrochloride?
Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see OVERDOSAGE section). To report SUSPECTED ADVERSE REACTIONS, contact Allucent at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See the full label for the complete list.
Who makes Phenazopyridine Hydrochloride?
Phenazopyridine Hydrochloride is listed by 18 labelers in the FDA NDC directory, including A-S Medication Solutions, Amneal Pharmaceuticals LLC, Bryant Ranch Prepack, Chartwell RX, LLC.
Has Phenazopyridine Hydrochloride been recalled?
The FDA enforcement database lists 1 recall for Phenazopyridine Hydrochloride, most recently D-0545-2024 (class ii): Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.