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Azo

urinary pain relief · Azo is an over-the-counter drug containing urinary pain relief, made by i-Health, Inc..

Type
Over the counter
Drug class
Not classified
Route
Oral
Manufacturers
1

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

Drug facts

Generic name
urinary pain relief
Active ingredients
Phenazopyridine Hydrochloride
Dosage forms
Tablet
Label holder
i-Health, Inc.
Label updated
01/05/2026

Active ingredients

Drug Facts Active ingredient (in each tablet) Phenazopyridine Hydrochloride 95 mg

Purpose

Urinary analgesic

Uses

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

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

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. When using this product 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 use and ask doctor your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication.

Do not use

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

When using this product

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 use and ask a doctor

Stop use and ask doctor your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication.

Keep out of reach of children

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

Inactive ingredients

Microcrystalline cellulose, pregelatinized corn starch, hypromellose, povidine, croscarmellose sodium, polyethylene glycol, carnauba wax and vegetable magnesium stearate. May also contain corn starch.

Questions?

Distributed by i-Health, Inc. 25 Bacon Road, Enfield, CT 06082 Made in India. Most Trusted Brand based on Nielsen data through 3/23/2013. For questions, concerns, or to report an adverse event, call (800) 722-3476 www.azoproducts.com

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Tablet95 mgoral1

Manufacturers and labels

1 FDA label

  • i-Health, Inc.Shown hereLabel 01/05/2026 · NDC 49973-301Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Azo: common questions

What is Azo used for?
Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
Is Azo a prescription drug?
No. Azo is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Azo?
Yes. Other FDA-listed products with the same active ingredients include Maximum Strength Urinary Pain Relief, Good Neighbor Pharmacy Urinary Pain Relief, Leader Maximum Strength Urinary Pain Relief, Phenazopyridine Hydrochloride.
Who makes Azo?
i-Health, Inc. lists Azo with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 01/05/2026 · Label text is shown as published by the manufacturer. Not medical advice