FDA label 865fa4b3-fac1-4ba5-a217-75bba4105ea4

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
17084caf-4a82-4a0b-8130-d8ac1072b293
SPL ID
865fa4b3-fac1-4ba5-a217-75bba4105ea4
Version
1
Effective date
2012-03-20
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:51

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Since drowsiness, disorientation, and confusion may occur with the use of scopolamine, patients should be warned of the possibility and cautioned against engaging in activities that require mental alertness, such as driving a motor vehicle or operating dangerous machinery.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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

adverse reactions

ADVERSE REACTIONS Side effects are similar to those of atropine, i.e., dry mouth, flushing, tachycardia, mydriasis, blurred vision, or urinary retention. In susceptible individuals, there may be dryness of the skin and other signs and symptoms typical of anticholinergic drugs. Many persons are excessively susceptible to scopolamine, and toxic symptoms may occur; such symptoms are often very alarming. There are marked disturbances of the intellect, ranging from complete disorientation to an active delirium resembling that encountered in atropine poisoning. Many cases present marked somnolence, but in others this may be lacking. At times the pupils are dilated, the pulse rate is accelerated, and there is dryness of the mouth with a husky quality of the voice apparently due to laryngeal paralysis; these symptoms are often absent or very mild.

Reported adverse events (FAERS/openFDA)#

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