Home FDA labels 6e4b7736-563b-4a42-a730-c60e5eb76512 FDA label 6e4b7736-563b-4a42-a730-c60e5eb76512 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 5ce8b827-c1e6-d914-3d4d-3687140cf21a
SPL ID 6e4b7736-563b-4a42-a730-c60e5eb76512
Version 2
Effective date 2018-12-04
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 02:07:23 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 without consulting a doctor: when abdominal pain, nausea or vomiting are present if there has been a sudden change in a child's bowel movements that persists over 2 weeks for a period longer than 1 week if pregnant or nursing a baby
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.