Home FDA labels f83805f1-4c44-4ee7-9a2c-1a0032d49da2 FDA label f83805f1-4c44-4ee7-9a2c-1a0032d49da2 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 f50b167c-9ed5-4c01-ab50-d8e823d53ad3
SPL ID f83805f1-4c44-4ee7-9a2c-1a0032d49da2
Version 2
Effective date 2018-03-01
Source export date 2026-10-12
Source partition 3
Source file https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:34:06
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 TAMPER EVIDENT: Each tablet is individually sealed. Do not use if blister or foil is broken, torn, or missing. For institutional use only. This unit dose package is not child-resistant. If dispensed for outpatient use, a child resistant container should be utilized.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.