FDA label 9c3d159e-d376-474c-8215-eeda2135d71a

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
efabc3b6-395b-4a39-8e46-01240f26e016
SPL ID
9c3d159e-d376-474c-8215-eeda2135d71a
Version
4
Effective date
2018-08-28
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:22:03

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 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 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 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. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.

Reported adverse events (FAERS/openFDA)#

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