FDA label 5be89dba-e6e1-d084-e053-2a91aa0aa35d

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
78506c63-8061-499c-a57e-bdd88f805591
SPL ID
5be89dba-e6e1-d084-e053-2a91aa0aa35d
Version
2
Effective date
2017-10-19
Source export date
2026-08-01
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/d245bd7ce31d1d8ed63276109973402ece6c44860774da30f25b731cd7418983/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:35:42

Warnings cross-check#

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warnings

WARNINGS Ask a doctor before use if you have kidney disease allergies to foods, preservatives or dyes had a hypersensitive reaction to Phenazopyridine 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 reducer 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 more than two days you suspect you are having an adverse reaction to the medication. If pregnant or breast-feeding, ask a health professional before use.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been described, usually at overdose levels (see Overdosage Section).