FDA label 5339611a-ddfe-4c1b-984e-17c827a7144a
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
- b85b3ca0-89ce-44fe-b748-62e160e8c349
- SPL ID
- 5339611a-ddfe-4c1b-984e-17c827a7144a
- Version
- 2
- Effective date
- 2017-08-29
- Source export date
- 2026-09-28
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:20:17
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 | 5339611a-ddfe-4c1b-984e-17c827a7144a | id | |
| spl set id | b85b3ca0-89ce-44fe-b748-62e160e8c349 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Addiction does not occur, although vomiting, malaise, sweating and salivation have been reported in patients with parkinsonism upon sudden withdrawal of large doses of scopolamine. Scopolamine is one of the most important drugs of the belladonna group from the standpoint of poisoning; infants and young children are especially susceptible to the belladonna alkaloids. Scopolamine is usually stated more toxic than atropine. Idiosyncrasy is more common with scopolamine than with atropine and ordinary therapeutic doses sometimes cause alarming reactions.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS With nearly all antimuscarinic drugs, dry mouth is the first and dry skin is the second most common side effect. Thirst and difficulty in swallowing occur when the mouth and esophagus become sufficiently dry; chronic dry mouth also fosters dental caries. Suppression of sweating causes reflexive flushing and heat intolerance and can result in heat exhaustion or heat stroke in a hot environment; it also contributes to the hyperthermia seen in intoxication. Mydriasis frequently occurs, especially with scopolamine; photophobia and blurring of vision are consequences of mydriasis. Cycloplegia (which exacerbates blurred vision) occurs approximately concomitantly with mydriasis, but usually higher doses are required. In susceptible persons, especially the elderly, cycloplegia may contribute to an elevation of intraocular pressure. Difficulty in urination and urinary retention may occur. Tachycardia is a common side effect. Constipation, even bowel stasis, may occur. In the larger therapeutic doses, scopolamine may cause dizziness, restlessness, tremors, fatigue and locomotor difficulties.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.