warnings
WARNINGS: If rapid pulse, dizziness, or blurring of vision occurs, discontinue use immediately. Patients should be advised that urine will be colored blue when taking this medication. Do not exceed recommended dosage.
URELLE
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
- Brand name
- URELLE
- Generic name
- HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
- Manufacturer
- Viatris Specialty LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 1d80a11c-6f86-403b-85d4-32ec1924dbe9
- SPL ID
- a8f8f4f1-ad2a-40af-9089-764a459fb8fd
- Version
- 4
- Effective date
- 2015-01-13
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:18:34
| Harmonized routes |
|---|
| ORAL |
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 |
|---|---|---|---|
| brand name | URELLE | openfda.brand_name | |
| generic name | HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | openfda.generic_name | |
| manufacturer name | Viatris Specialty LLC | openfda.manufacturer_name | |
| ndc | package | 0037-6321-90 | openfda.package_ndc |
| ndc | product | 0037-6321 | openfda.product_ndc |
| ndc11 | package | 00037632190 | derived:openfda.package_ndc |
| rxcui | 1048340 | openfda.rxcui | |
| rxcui | 1048336 | openfda.rxcui | |
| spl id | a8f8f4f1-ad2a-40af-9089-764a459fb8fd | id | |
| spl set id | 1d80a11c-6f86-403b-85d4-32ec1924dbe9 | set_id | |
| unii | T42P99266K | openfda.unii | |
| unii | F2R8V82B84 | openfda.unii | |
| unii | J50OIX95QV | openfda.unii | |
| unii | 593YOG76RN | openfda.unii | |
| unii | 28A37T47QO | openfda.unii |
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
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8402 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.