FDA label 2d8ad8ad-3d20-4ba1-9dab-e2f300543972

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
31e608aa-f552-4c49-bf12-7da0963c62b1
SPL ID
2d8ad8ad-3d20-4ba1-9dab-e2f300543972
Version
1
Effective date
2013-10-25
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 06:11:45

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS: Not for injection into the eye. Do not touch dropper tip to any surface, as this may contaminate the solution. In pediatric patients, use with extreme caution. Excessive use in pediatric patients or in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning. If this occurs, discontinue medication, and use appropriate therapy as outlined in “ OVERDOSAGE ” section.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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 the very young.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.