Uristat Ultra

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
Uristat Ultra
Generic name
PHENAZOPYRIDINE HYDROCHLORIDE
Manufacturer
Medtech Products Inc.
Product type
HUMAN OTC DRUG
SPL set ID
c705185f-4908-451e-993b-b0b8a73f0392
SPL ID
14db261b-912d-4675-b681-4162d783ae1d
Version
4
Effective date
2025-10-23
Source export date
2026-11-06
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:09:54
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 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 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 experience a yellowish tinge of skin or eyes experience fevers chills, back pain or bloody urine If pregnant or breast-feeding, ask a health care professional before 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.