AZO

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)

Brand name
AZO
Generic name
URINARY PAIN RELIEF
Manufacturer
i-Health, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
3d0298b7-eaec-488b-9cab-19af4614ff53
SPL ID
47a4fa0f-9c93-6286-e063-6394a90aa070
Version
8
Effective date
2026-01-05
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:17:14
Harmonized routes table
Harmonized routes
ORAL

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. 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 in color. This is not harmful, but care should be taken to avoid staining clothing or other items. Stop use and ask doctor your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication.

Reported adverse events (FAERS/openFDA)#

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