Home FDA labels 678ddf7f-9740-4c05-ad8c-99ef08f6a172 FDA label 678ddf7f-9740-4c05-ad8c-99ef08f6a172 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 a0c0fa74-0e98-4737-8a6e-96bb0dd57590
SPL ID 678ddf7f-9740-4c05-ad8c-99ef08f6a172
Version 4
Effective date 2021-12-28
Source export date 2026-10-12
Source partition 8
Source file https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:08:12 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: IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF THE REACH OF CHILDREN. If symptoms worsen or persist for more than 5 days, discontinue use and contact a health care professional. KEEP OUT OF THE REACH OF CHILDREN.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.