Home FDA labels fb4771cd-f474-e2bd-e053-6394a90aa83e FDA label fb4771cd-f474-e2bd-e053-6394a90aa83e 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 ba26fc95-c10c-4c35-93a6-aea6f93a2db2
SPL ID fb4771cd-f474-e2bd-e053-6394a90aa83e
Version 2
Effective date 2023-05-09
Source export date 2026-11-06
Source partition 13
Source file https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run 20261108T063105Z
Imported at 2026-11-08 08:07:59 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 Do not use more than directed. As with any supplement, if you are pregnant or nursing a baby, contact your healthcare professional before use. The seal of the package bears our name, Roxane. If the seal is broken or our name does not appear, do not use.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.