warnings
WARNINGS FOR TOPICAL OPHTHALMIC USE ONLY – NOT FOR INJECTION. Excessive use in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning.
FDA label 472b0577-8988-6c1f-9eff-e9e50db36c10
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
- 6fdb0fa2-83bd-4d23-bf66-267b10f3121a
- SPL ID
- 472b0577-8988-6c1f-9eff-e9e50db36c10
- Version
- 3
- Effective date
- 2011-09-23
- Source export date
- 2026-09-28
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:51:11
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 | 472b0577-8988-6c1f-9eff-e9e50db36c10 | id | |
| spl set id | 6fdb0fa2-83bd-4d23-bf66-267b10f3121a | set_id |
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
ADVERSE REACTIONS Prolonged use may produce local irritation character ized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis. Severe reactions are manifested by hypotension with progressive respiratory depression. Coma and death have been reported in the very young.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.