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 ...
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.
www.fda.gov/medwatchRx Only
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:
C11H11N5 ∙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.
Phenazopyridine HCl is excreted in the urine where it exerts a topical analgesic effect on the mucosa of the urinary tract. This action helps to relieve pain, burning, urgency and frequency. The precise mechanism of action is not known.
The pharmacokinetic properties of Phenazopyridine HCl have not been determined. Phenazopyridine HCl is rapidly excreted by the kidneys, with as much as 66% of an oral dose being excreted unchanged in the urine.
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).
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.
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.
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.
Due to its properties as an azo dye, Phenazopyridine HCl may interfere with urinalysis based on spectrometry or color reactions.
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.
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.
No information is available on the appearance of Phenazopyridine HCl, or its metabolites in human milk.
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.
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.
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].
Distributed by:
Genus Lifesciences, Inc
Allentown, PA 18102
Rev. 06/2026
NDC 64950-550-01
Phenazopyridine
Hydrochloride
Tablets, USP
100 mg
Rx only
100 Tablets
Genus
Lifesciences Inc.
NDC 64950-551-01
Phenazopyridine
Hydrochloride
Tablets, USP
200 mg
Rx only
100 Tablets
Genus
Lifesciences Inc.
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0364950550016 | GTIN-13: 0364950550016 EAN-13: 0364950550016 GTIN-12: 364950550016 UPC-A: 364950550016 GTIN storage (14 digits): 00364950550016 | phenazopyridine-02.jpg |
| Barcode | EAN-13 | 0364950551013 | GTIN-13: 0364950551013 EAN-13: 0364950551013 GTIN-12: 364950551013 UPC-A: 364950551013 GTIN storage (14 digits): 00364950551013 | phenazopyridine-03.jpg |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 64950-550 | 64950-550-01 |
| 64950-551 | 64950-551-01 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-06-05 | daily-update | 2026-06-11 05:11:39 |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PHENAZOPYRIDINE HYDROCHLORIDE | PHENAZOPYRIDINE HYDROCHLORIDE | Genus Lifesciences Inc. | 991b3b97-9cea-4c48-90a4-ebff55417d98 | 2026-07-14 | Adverse reactions | 64950-551-01 64950-550-01 64950-551 64950-550 64950055101 64950055001 af00a22c-46a2-4a41-b37e-cffebedead20 991b3b97-9cea-4c48-90a4-ebff55417d98 |
Adverse event summaries are temporarily unavailable. Other product information remains available.