Home FDA labels 4e7c95fd-efb6-4d65-b2a2-4fb853295b9c FDA label 4e7c95fd-efb6-4d65-b2a2-4fb853295b9c 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 16f212c3-d504-4d3c-813e-cc23a04aaa88
SPL ID 4e7c95fd-efb6-4d65-b2a2-4fb853295b9c
Version 3
Effective date 2023-07-05
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 05:17:36 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.
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 With large doses of ephedrine sulfate most patients will experience nervousness, insomnia, vertigo, headache, tachycardia, palpitation and sweating. Some patients have nausea, vomiting and anorexia. Vesical sphincter spasm may occur and result in difficult and painful urination. Urinary retention may develop in males with prostatism. Primordial pain and cardiac arrhythmias may occur following administration of Ephedrine Sulfate Injection, USP
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.