FDA label 6f17462c-4ed2-47b2-ba13-287c347cb2cc
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
- cbe3834f-6eff-49d9-9e08-42acd2c20eb5
- SPL ID
- 6f17462c-4ed2-47b2-ba13-287c347cb2cc
- Version
- 1002
- Effective date
- 2013-04-25
- Source export date
- 2026-09-28
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:13:16
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 | 6f17462c-4ed2-47b2-ba13-287c347cb2cc | id | |
| spl set id | cbe3834f-6eff-49d9-9e08-42acd2c20eb5 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: Contains Sodium Bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. For topical ophthalmic use only. As with all other adrenergic drugs, when administered simultaneously, or up to 21 days other administration of monoamine oxidase (MAO) inhibitors, careful supervision and adjustment of dosages are required since exaggerated adrenergic effects may result. The pressor response of adrenergic agents may also be potentiated by tricyclic antidepressants. There have been rare reports associating the use of phenylephrine hydrochloride 10 percent ophthalmic solutions with the development of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infractions. These episodes, some ending fatally, have usually occurred in elderly patients with preexisting cardiovascular diseases.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Phenylephrine is a sympathomimetic drug related to epinephrine and ephedrine, and that even though it is rare, it may produce such reactions as tremor, pallor, perspiration, abnormal palpitation or collapse.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.