Home FDA labels 0055b112-9820-4fad-b7e0-58264b97fb60 FDA label 0055b112-9820-4fad-b7e0-58264b97fb60 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 08c4538a-836e-4d14-9143-245a77346b23
SPL ID 0055b112-9820-4fad-b7e0-58264b97fb60
Version 3
Effective date 2014-08-14
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 02:07:22 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 if the blister pack is broken. Ask a doctor before use in children under 2 years of age. Stop use and ask a doctor if symptoms persist for more than 3 days or worsen. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.