FDA label 8809b9b9-34c0-4803-acd2-fe88bc53be34

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
f0ca6986-74d1-40e8-af10-ce3de40be377
SPL ID
8809b9b9-34c0-4803-acd2-fe88bc53be34
Version
3
Effective date
2015-01-02
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:23:18

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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#

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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.