FDA label c25ed7eb-f5c7-4e60-bfcd-1d3fafef1987
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
- 9951c888-4b6a-4c76-a9c1-dc3a0c777191
- SPL ID
- c25ed7eb-f5c7-4e60-bfcd-1d3fafef1987
- Version
- 2
- Effective date
- 2020-11-03
- Source export date
- 2026-09-28
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:13:05
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 | c25ed7eb-f5c7-4e60-bfcd-1d3fafef1987 | id | |
| spl set id | 9951c888-4b6a-4c76-a9c1-dc3a0c777191 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS NOT FOR INJECTION – FOR OPHTHALMIC USE ONLY. Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug. Use in children, especially infants, may result in CNS depression leading to coma and marked reduction in body temperature. Remove contact lenses before using.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Ocular: Mydriasis, increased redness, irritation, discomfort, blurring, punctuate keratitis, lacrimation, increased intraocular pressure. Systemic: Dizziness, headache, nausea, sweating, nervousness, drowsiness, weakness, hypertension, cardiac irregularities, and hyperglycemia.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.