Medicine guide

Azo

95 mg · Tablet

  • Available without prescription
Active substance
Urinary Pain Relief
Made by
i-Health, Inc.

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 · 2026-01-05

What it is

Urinary analgesic

Used for
  • Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
How to take it

Adults and children 12 years or older:: take 2 tablets 3 times daily with or after meals as needed for up to two days.

Full directions ↓
Do not take it if

Do not use this product

All warnings ↓
Good to know
  • Sold without a prescription
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

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

What it is for

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

From the official label · 2026-01-05 · DailyMed

Do not take it if

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

Quoted from the official label, section “OTC — Do Not Use”.

How to take it

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

  • 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.

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

Stop and get help if

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

Quoted from the official label, section “OTC — Stop Use”.

Other 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:
  • 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
  • Other Inf ormation 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
  • 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.
  • 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.

Quoted from the official label, section “Warnings”.

Keep away from children

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

Quoted from the official label, section “OTC — Keep Out of Reach of Children”.

What kind of medicine it is

Urinary analgesic

Quoted from the official label, section “OTC — Purpose”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

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

Quoted from the official label, section “Inactive Ingredients”.

Questions about this product

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

Quoted from the official label, section “OTC — Questions”.

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.

Details

Made byi-Health, Inc.
Active substanceUrinary Pain Relief
Strength95 mg
FormTablet
RouteOral
Packs15 BLISTER PACK in 1 BOX / 2 TABLET in 1 BLISTER PACK
NDC49973-301

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).