FDA label bf5d1df2-0988-4a34-ada1-78262b9b2edc

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
7fffcb3d-c7d3-4410-a60b-7fcc8e6098c9
SPL ID
bf5d1df2-0988-4a34-ada1-78262b9b2edc
Version
2
Effective date
2012-05-16
Source export date
2026-10-12
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/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:47:56

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Drowsiness or dizziness may occur. Patients should be instructed to use caution in driving or operating machinery. Not to be used by persons having glaucoma or excessive pressure within the eye, by elderly persons (where undiagnosed glaucoma or excessive pressure within the eye occurs most frequently), or by children under 6 years of age, unless directed by a physician. Discontinue use if blurring of vision, rapid pulse, or dizziness occurs. Do not exceed recommended dosage. Not for frequent or prolonged use. If dryness of the mouth occurs, decrease dosage. If eye pain occurs, discontinue use and see your physician immediately as this may indicate undiagnosed glaucoma.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Headache, rash, pruritus and occasional gastrointestinal disturbance. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been described for phenazopyridine, usually at overdose levels (see OVERDOSAGE section). An anaphylactoid-like reaction has been described. Hyoscyamine hydrobromide is an atropinic drug that may produce adverse effects characteristic of this class of drugs. Dry mouth, drowsiness or dizziness is noted in more than one-third of patients (and may occur in half of the patients of older age groups). Other atropine-like effects such as blurred vision may occur. There may be occasional gastrointestinal disturbances. Butabarbital is a short-to-intermediate acting barbiturate which has the potential for adverse reactions attributable to barbiturates.

Reported adverse events (FAERS/openFDA)#

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