FDA label 8de347a4-edcc-44c5-e053-2a95a90ae0a9

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
89671985-3829-62cd-e053-2995a90a6113
SPL ID
8de347a4-edcc-44c5-e053-2a95a90ae0a9
Version
2
Effective date
2019-07-17
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:28:33

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

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. If pregnant or breast-feeding , 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 (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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