warnings
PATIENT WARNINGS Patient should be advised not to drive or engage in other hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation.
FDA label 0b437741-e67d-00ac-23d6-f7fe0488cfd4
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
- e905ea0c-e44d-4c91-57bc-f288f625e505
- SPL ID
- 0b437741-e67d-00ac-23d6-f7fe0488cfd4
- Version
- 2
- Effective date
- 2011-09-20
- Source export date
- 2026-10-12
- Source partition
- 6
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:48:52
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 | 0b437741-e67d-00ac-23d6-f7fe0488cfd4 | id | |
| spl set id | e905ea0c-e44d-4c91-57bc-f288f625e505 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings and cautions
WARNINGS For topical eye use only, not for injection. Use with extreme caution in infants, small children and geriatrics. Excessive use in children or in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning.
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 characterized 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 young children. Increase in IOP may occur in patients with open angle glaucoma. Photophobia may occur with a fixed and dilated pupil. Decreased lacrimation may aggravate a dry eye condition.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.