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
- 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
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 | 865fa4b3-fac1-4ba5-a217-75bba4105ea4 | id | |
| spl set id | 17084caf-4a82-4a0b-8130-d8ac1072b293 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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
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.