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Phenazopyridine Hydrochloride

OTC RxCUI 1094147
Contents

Overview

Label date
2025-11-10

Indications and usage

Use Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions.

Purpose

Active ingredient (in each tablet) Purpose Phenazopyridine Hydrochloride 99.5mg Urinary Tract Analgesic

Dosage and administration

Directions Adults and children 12 years and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed Do not use for more than 2 days (12 tablets) without consulting a doctor. Children under 12 years: consult a doctor

Warnings

Do not exceed recommended dosage Do Not Use Do not use : If you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician Ask A Doctor Before Use Ask a doctor before use if you have: kidney disease allergies to foods, preservatives or dyes had a hypersensitive reaction to phenazopyridine When Using This Product 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 a doctor if : your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication Long Term Administration Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted. If Pregnant or Breast Feeding If pregnant or breast feeding, ask a health professional before use. Keep Out Of The Reach Of Children Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222

Do not use

Do not use : If you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician

Ask a doctor before use if

Ask A Doctor Before Use Ask a doctor before use if you have: kidney disease allergies to foods, preservatives or dyes had a hypersensitive reaction to phenazopyridine

When using this product

This Product 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 if

And Ask A Doctor Stop use and ask a doctor if : your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication

Pregnancy or breast-feeding

If Pregnant or Breast Feeding If pregnant or breast feeding, ask a health professional before use.

Active ingredient (label)

(in each tablet) Phenazopyridine Hydrochloride 99.5 mg

Inactive ingredients

s corn starch, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc and triacetin.

Storage and handling

Other Information this product may stain contact lenses this product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests store at room temperature 15°-30°C (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

Keep out of reach of children

Keep Out Of The Reach Of Children Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222