Home FDA labels 3b0cda32-9a19-453c-87c1-ba37704ba15e FDA label 3b0cda32-9a19-453c-87c1-ba37704ba15e 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 f38e3e0a-1153-4849-8f8c-6f67cd7d33d8
SPL ID 3b0cda32-9a19-453c-87c1-ba37704ba15e
Version 4
Effective date 2021-03-25
Source export date 2026-10-12
Source partition 11
Source file https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:47:44 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 WARNING: Consult a physician for use in children under 12 years of age. IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away. KEEP OUT OF THE REACH OF CHILDREN.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.