Home FDA labels b15405fe-57d4-4915-9868-7994adfed2d3 FDA label b15405fe-57d4-4915-9868-7994adfed2d3 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 12b234e4-e832-4861-bc0e-ad867a92384b
SPL ID b15405fe-57d4-4915-9868-7994adfed2d3
Version 2
Effective date 2021-09-28
Source export date 2026-10-12
Source partition 4
Source file https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:38:36 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.
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 oral (sublingual) use. Ask a doctor before use in children under 3 years of age. Stop use and ask doctor if symptoms persist for more than 3 days or worsen. If pregnant or breast-feeding ask a doctor before use. Keep out of reach of children.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.