Mediclarum
Medicine guide

Phenazopyridine Hydrochloride

200 mg · Tablet

  • Prescription only
Active substance
Phenazopyridine
Made by
Northwind Health Company, LLC

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-01-01

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,…
The label’s usual adult dose

100 mg Tablets:

Full directions ↓
Do not take it if

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.

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
16other products contain Phenazopyridine — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is 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 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).

From the official label · 2026-01-01 · DailyMed

How it works

From this product’s own US prescribing label.

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.

How it leaves the body

Phenazopyridine HCl is excreted in the urine where it exerts a topical analgesic effect on the mucosa of the urinary tract.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-01-01

Do not take it if

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.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • 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.
  • Nursing Mothers No information is available on the appearance of Phenazopyridine HCl, or its metabolites in human milk.
  • 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.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • 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.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • 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.

Quoted from the official label, section “Overdosage”.

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 Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

  • 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.
  • They are supplied as follows:
  • Bottles of 6 NDC 51655-424-87 Bottles of 10 NDC 51655-424-53 Bottles of 12 NDC 51655-424-27 DISPENSE contents with a child-resistant closure (as required) and in a tight container as defined in the USP.
  • STORE at 20° to 25°C (68° to 77°F); excursions permitted between15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
  • Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 06-2020-01

Quoted from the official label, section “How Supplied”.

What is in it

  • 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. chem structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (17)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Hide versions whose label lists:

Showing 17 of 17

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Canada2 matching products

Every strength and form (4)

Details

Made byNorthwind Health Company, LLC
Active substancePhenazopyridine
Strength200 mg
FormTablet
RouteOral
Packs12 TABLET in 1 BOTTLE, PLASTIC · 10 TABLET in 1 BOTTLE, PLASTIC
NDC51655-424

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

32 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Phenazopyridine Hydrochloride200 mgPrescription onlyTablet A-S Medication Solutions · PhenazopyridinePhenazopyridine Hydrochloride100 mgPrescription onlyTablet A-S Medication Solutions · PhenazopyridinePhenazopyridine Hydrochloride100 mgPrescription onlyTablet Northwind Health Company, LLC · PhenazopyridinePhenazopyridine Hydrochloride100 mgPrescription onlyTablet Amneal Pharmaceuticals LLC · PhenazopyridinePhenazopyridine Hydrochloride200 mgPrescription onlyTablet Amneal Pharmaceuticals LLC · PhenazopyridinePhenazopyridine Hydrochloride100 mgPrescription onlyTablet NuCare Pharmaceuticals,Inc. · Phenazopyridine

See every product with Phenazopyridine