Home FDA labels 38c4fae3-eb30-4583-901c-ece8ad8dbe82 FDA label 38c4fae3-eb30-4583-901c-ece8ad8dbe82 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 61421686-bb86-449a-802f-b1ffa66e9ff4
SPL ID 38c4fae3-eb30-4583-901c-ece8ad8dbe82
Version 3
Effective date 2018-09-10
Source export date 2026-09-28
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/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:22:26 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 you are pregnant or breast-feeding, seek the advice of a doctor before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. DO Not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.