AZO Urinary Pain Relief (phenazopyridine hydrochloride)

Generic name: phenazopyridine hydrochloride · Brand names: AZO Urinary Pain Relief, AZO Urinary Pain Relief Maximum Strength

Quick facts

Drug class

Purpose per Drug Facts: Urinary analgesic

Rx or otc

OTC (DailyMed: HUMAN OTC DRUG; Marketing Category: unapproved drug other)

Forms and strengths

Tablet, phenazopyridine hydrochloride 95 mg (Drug Facts: Active ingredient (in each tablet))

Common use one line

Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections (Drug Facts: Use).

What it is used for

It relieves urinary pain, burning, urgency and frequency that come with urinary tract infections. It treats symptoms only; the Drug Facts label does not say it treats the infection.

Section

Drug Facts: Use

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Confidence

high

Source text (exact source wording)

Use: Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

How it works

Confidence

high

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Dosage: adults

Adults and children 12 and older take 2 tablets 3 times daily with or after meals as needed, with a full glass of water, for up to two days. Do not use for more than 2 days (12 tablets) without a doctor.

Section

Drug Facts: Directions

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Confidence

high

Source text (exact source wording)

Directions: Adults and children 12 years or older: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor.

Dosage: children

Children under 12 should not use it without a doctor.

Section

Drug Facts: Directions

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Confidence

high

Source text (exact source wording)

Children under 12: Do not use without consulting a doctor.

Dosage adjustments

Drug interaction caps

Confidence

high

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Kidney

Ask a doctor before use if you have kidney disease.

Section

Drug Facts: Warnings

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Confidence

high

Source text (exact source wording)

Ask a doctor before use if you have kidney disease

Liver

Confidence

high

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Elderly

Confidence

high

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Missed dose

Confidence

high

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Overdose

In case of overdose, get medical help or contact Poison Control right away (1-800-222-1222).

Section

Drug Facts

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Confidence

high

Source text (exact source wording)

Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.

Storage

Store at room temperature (59-86 F) in a dry place, away from light. Do not use if the blister foil or seal is open or damaged.

Section

Drug Facts: Other Information

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Confidence

high

Source text (exact source wording)

Store at room temperature (59-86 F) in a dry place and protect from light. Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged.

Boxed warning

NONE

Contraindications

Do not use if you have G6PD deficiency unless your physician approves.

Section

Drug Facts: Warnings

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Confidence

high

Source text (exact source wording)

Caution: Do not use this product if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

Ask a doctor first if you have kidney disease, allergies to foods, preservatives or dyes, or ever had a reaction to phenazopyridine. (These are 'ask a doctor' items, not formal contraindications.)

Section

Drug Facts: Warnings

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Confidence

high

Source text (exact source wording)

Ask a doctor before use if you have: kidney disease; allergies to foods, preservatives or dyes; had a hypersensitive reaction to Phenazopyridine Hydrochloride.

Warnings and precautions

Heading

Warnings (Drug Facts)

Section

Drug Facts: Warnings

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Confidence

high

Source text (exact source wording)

Warnings Please read insert for important precautions. Ask a doctor before use if you have kidney disease; allergies to foods, preservatives or dyes; had a hypersensitive reaction to Phenazopyridine Hydrochloride. Caution: Do not use this product if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

Stomach upset may occur; taking it with or after meals may help. Urine turns reddish-orange, which is not harmful, but can stain clothing.

Heading

When using this product

Section

Drug Facts: When using this product

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Confidence

high

Source text (exact source wording)

stomach upset may occur, taking this product with or after meals may reduce stomach upset. your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items.

Stop and ask a doctor if symptoms last more than 2 days or you suspect an adverse reaction.

Heading

Stop use and ask doctor

Section

Drug Facts: Stop use and ask doctor

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Confidence

high

Source text (exact source wording)

your symptoms last for more than 2 days. you suspect you are having an adverse reaction to the medication.

It can interfere with urine, glucose and ketone lab tests and may stain soft contact lenses.

Heading

Other information (lab tests, contact lenses)

Section

Drug Facts: Other Information

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Confidence

high

Source text (exact source wording)

This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests. This product may stain soft contact lenses and other items if handled after touching tablets.

Pregnancy and breastfeeding

Confidence

high

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Side effects

Common

The label gives no percentages. It names stomach upset and reddish-orange urine.

Section

Drug Facts

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Confidence

high

Threshold

none stated by label

Less common

Confidence

high

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Serious

Confidence

high

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Led to discontinuation

Confidence

high

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Interactions

Food and alcohol

Name

Food

Section

Drug Facts: When using this product

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Source text (exact source wording)

taking this product with or after meals may reduce stomach upset.

Other

Can interfere with urine, glucose and ketone tests.

Name

Laboratory tests

Section

Other Information

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Source text (exact source wording)

This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests

Patient tips

Label

Expect orange-red urine; it can stain. Take with a full glass of water and do not use more than 2 days without a doctor.

Section

Drug Facts

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Source text (exact source wording)

your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor.

Alternatives

Class source

Drug Facts Purpose: Urinary analgesic. openFDA EPC not checked.

Frequently asked questions

Question

What is AZO Urinary Pain Relief used for?

Answer

Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

Source section

Drug Facts: Use

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Question

How do I take it?

Answer

Adults and children 12 and older take 2 tablets 3 times daily with or after meals as needed, with a full glass of water, for up to two days.

Source section

Directions

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Question

How long can I use it?

Answer

Do not use for more than 2 days (12 tablets) without consulting a doctor. Stop and ask a doctor if symptoms last more than 2 days.

Source section

Directions; Stop use

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Question

Why is my urine orange?

Answer

Your urine will become reddish-orange in color. This is not harmful, but it can stain clothing or other items.

Source section

When using this product

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Question

Can children use it?

Answer

Children 12 and older follow the adult directions. Children under 12 should not use it without consulting a doctor.

Source section

Directions

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Question

Who should not use it?

Answer

Do not use it if you have G6PD deficiency unless your physician approves. Ask a doctor first if you have kidney disease or allergies to foods, preservatives or dyes.

Source section

Warnings

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Question

Does it affect lab tests or contact lenses?

Answer

It can interfere with urine, glucose and ketone tests, and may stain soft contact lenses.

Source section

Other Information

Source

DailyMed printer-friendly label, i-Health, Inc. AZO Urinary Pain Relief tablet (phenazopyridine HCl 95 mg), set ID 3d0298b7-eaec-488b-9cab-19af4614ff53

Sources

DailyMed AZO Urinary Pain Relief, i-Health, Inc. (chosen)
Set id: 3d0298b7-eaec-488b-9cab-19af4614ff53 · Label effective or revised date: Revised: 1/2026 · Dailymed version date: List API published Jan 06, 2026 · Fetched at: 2026-11-02 · Sections used: Drug Facts, Product Information, Marketing Information
Alternate (not opened): AZO Urinary Pain Relief Maximum Strength, i-Health
Set id: b4874fe2-d98b-4b5c-baad-d75070947842 · Label effective or revised date: label not opened · Dailymed version date: List API published Nov 26, 2025 · Fetched at: 2026-11-02 · Sections used: none

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug