FDA label 2bac8ca4-084d-af28-e063-6394a90a010a

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
9607b733-0f3a-4a2c-8057-41d0a5df070d
SPL ID
2bac8ca4-084d-af28-e063-6394a90a010a
Version
6
Effective date
2025-01-14
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:57:34

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS In the presence of high environmental temperature, heat prostration (fever and heatstroke 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#

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

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.