Home FDA labels 1e9f984a-685f-4c98-b4d4-683445950448 FDA label 1e9f984a-685f-4c98-b4d4-683445950448 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 d21406a4-0d17-4dfc-a5db-304e217ee319
SPL ID 1e9f984a-685f-4c98-b4d4-683445950448
Version 1
Effective date 2010-10-29
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 01:29:34 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings WARNINGS Use in Pregnancy Pregnancy category C Safety for use during pregnancy has not been established. Nursing Mothers Use with caution in nursing mothers. Special Risk Patients Use with caution in patients with hypertension or ischemic heart disease, and persons older than 60 years.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions ADVERSE REACTIONS Antihistamines: sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn weakness, polyuria and dysuria and, rarely, excitability in children. Sympathomimetic amines: Convulsions, CNS stimulation, cardiac arrhythmias, respiratory difficulty, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, weakness, pallor and dysuria.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.