FDA label 163bb50a-cf7b-e61b-e063-6394a90a6391
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
- 1c74eb71-165f-4667-80f2-ee2b4a231054
- SPL ID
- 163bb50a-cf7b-e61b-e063-6394a90a6391
- Version
- 2
- Effective date
- 2024-04-16
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:17:40
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 | 163bb50a-cf7b-e61b-e063-6394a90a6391 | id | |
| spl set id | 1c74eb71-165f-4667-80f2-ee2b4a231054 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS In the presence of high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with drug use. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful. Methscopolamine bromide may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug. With overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The following adverse reactions have been observed, but there is not enough data to support an estimate of frequency. Cardiovascular: Tachycardia, palpitation. Allergic: Severe allergic reaction or drug idiosyncrasies including anaphylaxis. CNS: Headaches, nervousness, mental confusion, drowsiness, dizziness. Special Senses: Blurred vision, dilation of the pupil, cycloplegia, increased ocular tension, loss of taste. Renal: Urinary hesitancy and retention. Gastrointestinal: Nausea, vomiting, constipation, bloated feeling. Dermatologic: Decreased sweating, urticaria and other dermal manifestations. Miscellaneous: Xerostomia, weakness, insomnia, impotence, suppression of lactation.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.