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Phenazopyridine Hydrochloride

Dosage form
TABLET
Labeler
GPT Pharmaceuticals Private Limited
Label updated
2026-05-12
Retrieved
2026-09-07
Active ingredients
PHENAZOPYRIDINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Label information

Drug Facts

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg

Purpose

Urinary tract analgesic

Uses

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

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.

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

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
Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

[Image in the official label — see DailyMed source]

DailyMed Set ID: 7332cbf1-ceda-415b-b4d5-a100057a7d01 · Version 1
NDC: 50696-003