FDA label 4189a3da-9b20-4c9e-b7b5-62dba3612c0f
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
- cc482d43-85d3-4aa1-8de4-a7385ea4536b
- SPL ID
- 4189a3da-9b20-4c9e-b7b5-62dba3612c0f
- Version
- 1
- Effective date
- 2010-10-29
- 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 02:48:07
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 | 4189a3da-9b20-4c9e-b7b5-62dba3612c0f | id | |
| spl set id | cc482d43-85d3-4aa1-8de4-a7385ea4536b | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Sympathomimetic amines should be used cautiously in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions. Stimulants, such as phenylephrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Side effects include xerostomia, blurred vision, bradycardia, mydriasis, flushing, palpitation, dizziness, constipation, urinary retention, drowsiness, increased irritability or excitability, nausea or dysphagia.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.