Home FDA labels 3631fe3e-a27e-4721-e063-6294a90aaa4f FDA label 3631fe3e-a27e-4721-e063-6294a90aaa4f 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 462a2822-b2e9-4d63-8706-0755c2ca0a21
SPL ID 3631fe3e-a27e-4721-e063-6294a90aaa4f
Version 1
Effective date 2025-05-28
Source export date 2026-09-28
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/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:15:26 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 For external use only. Not suitable for epileptics Not suitable for people with uncontrolled hyper-tension. Not recommended during pregnancy and lactation Not suitable for individuals with known sensitivity to any of the ingredients. Avoid contact with eyes.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.