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Phenazopyridine Hydrochloride

OTC Oral RxCUI 1094147
Contents

Overview

Active ingredient
Phenazopyridine Hydrochloride
Route
Oral
Label date
2026-05-12

Indications and usage

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

Purpose

Urinary tract analgesic

Dosage and administration

Directions Adults and children 12 years and 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

Do not exceed recommended dosage. Ask a doctor before use if you have kidney disease allergies to foods, preservatives or dyes had a hypersensitive reaction to Phenazopyridine Hydrochloride Do not use 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 if your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication 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 breastfeeding, ask a health professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use. Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center call (1-800-222-1222) right away.

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 if you have kidney disease allergies to foods, preservatives or dyes had a hypersensitive reaction to Phenazopyridine Hydrochloride

When using this product

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

Pregnancy or breast-feeding

If pregnant or breastfeeding, ask a health professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.

Active ingredient (label)

(in each tablet) Phenazopyridine Hydrochloride 99.5 mg

Inactive ingredients

s colloidal silicone dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, maize (corn) starch, microcrystalline cellulose, povidone, pregelatinized starch

Storage and handling

Other information This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests This product may stain contact lenses and other items if handled after touching tablets. Store in a tightly closed container

Keep out of reach of children

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