Home FDA labels 9f2f9a5b-96e5-285d-e053-2a95a90a0a86 FDA label 9f2f9a5b-96e5-285d-e053-2a95a90a0a86 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 94ff6d60-1af0-2638-e053-2a95a90ad39b
SPL ID 9f2f9a5b-96e5-285d-e053-2a95a90a0a86
Version 2
Effective date 2020-02-22
Source export date 2026-09-28
Source partition 10
Source file https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 06:09:12 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
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Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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warnings WARNINGS Heat prostration can occur with anticholinergic drug use (fever and heat stroke due to decreased sweating) in the presence of a high environmental temperature. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. Treatment of diarrhea with these drugs is inappropriate and possibly harmful. Usage in the elderly: Elderly patients may react with excitement, agitation, drowsiness and other untoward manifestations to even small doses of anticholinergic drugs. Usage in gastric ulcer may produce a delay in gastric emptying time and may complicate such therapy (antral stasis).
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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adverse reactions ADVERSE REACTIONS GI: Xerostomia; altered taste perception; nausea; vomiting; dysphagia; heartburn, constipation; bloated feeling; paralytic ileus; gastroesophageal reflux. GU: Urinary hesitancy and retention; impotence. Ocular: Blurred vision; mydriasis; photophobia; cycloplegia; increased intraocular pressure. Cardiovascular: Palpitations; bradycardia (following low doses of atropine); tachycardia (after higher doses). CNS: Headache; flushing; nervousness; drowsiness; weakness; dizziness; insomnia; fever. Elderly patients may exhibit mental confusion or excitement to even small doses. Large doses may produce CNS stimulation (restlessness, tremor). Dermatologic - Hypersensitivity: Severe allergic reactions including anaphylaxis, urticaria and other dermal manifestations. Other: Suppression of lactation; nasal congestion; decreased sweating. Complete anhidrosis cannot occur because large doses would be required, producing severe side effects from parasympathetic paralysis.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.