Maximum Strength Urinary Pain Relief

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
Maximum Strength Urinary Pain Relief
Generic name
PHENAZOPYRIDINE HYDROCHLORIDE
Manufacturer
Advanced Rx LLC
Product type
HUMAN OTC DRUG
SPL set ID
a10464cf-36b2-460f-b31c-2e0edee3e4cf
SPL ID
1b87f423-20e1-743e-e063-6294a90aaa03
Version
1
Effective date
2024-05-01
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 06:15:16
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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 right away.

Reported adverse events (FAERS/openFDA)#

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