Home FDA labels 83c70a87-914d-4d60-aa14-fd9c3991ba2a FDA label 83c70a87-914d-4d60-aa14-fd9c3991ba2a 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 3aacedcf-2e00-46ed-81d6-9a1500be7975
SPL ID 83c70a87-914d-4d60-aa14-fd9c3991ba2a
Version 2
Effective date 2014-08-19
Source export date 2026-10-12
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/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:29:43 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 Warnings: If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. If symptoms persist or worsen, a healthcare professional should be consulted. Do not use if known sensitivity to Back or any of its ingredients exists.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.