Home FDA labels 301b6b2b-bc36-4cbe-95b0-087d6cac7dfc FDA label 301b6b2b-bc36-4cbe-95b0-087d6cac7dfc 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 ca8e8b7c-2f82-42d4-99a8-640ca3c84be2
SPL ID 301b6b2b-bc36-4cbe-95b0-087d6cac7dfc
Version 2
Effective date 2017-11-02
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 01:36:18
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 WARNING: KEEP OUT OF THE REACH OF CHILDREN. IF PREGNANT OR BREAST FEEDING, ask a health professional before use. If symptoms worsen or persist, discontinue use and consult with your doctor. Do not use if seal is broken. Keep out of the reach of children.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.