warnings
WARNING Drowsiness or dizziness may occur. Patients should be instructed to use caution in driving or operating machinery.
FDA label b5c22ac0-3fd2-422c-856c-189908dcfbc9
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
- SPL set ID
- b5c22ac0-3fd2-422c-856c-189908dcfbc9
- SPL ID
- b5c22ac0-3fd2-422c-856c-189908dcfbc9
- Version
- 1
- Effective date
- 2010-05-10
- Source export date
- 2026-09-28
- 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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:21:59
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | b5c22ac0-3fd2-422c-856c-189908dcfbc9 | id | |
| spl set id | b5c22ac0-3fd2-422c-856c-189908dcfbc9 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Headache, rash, pruritus and occasional gastrointestinal disturbance. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been associated with phenazopyridine, usually at toxic 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, such as drowsiness, nausea, vomiting, abdominal pain, dizziness, and shortness of breath.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.