FDA label 5bf4ffe0-1ffc-4ab9-b687-30e772281a18

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
c179cb10-16ba-4707-a29d-794b2cb869f8
SPL ID
5bf4ffe0-1ffc-4ab9-b687-30e772281a18
Version
2
Effective date
2018-08-04
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:23

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Pleae 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 color. This is not harmful, but care should be taken to avoid staining clothing or other items. Stop use and ask doctor if • your symptoms last for more than 2 days • you suspect you are having an adverse reaction to the medication. If pregnant or breastfeeding , ask health professional before use.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.