Home FDA labels 6ed14b8d-aba7-4096-bbab-81cf7aecb8a8 FDA label 6ed14b8d-aba7-4096-bbab-81cf7aecb8a8 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 4d6a5aea-99f2-42da-b0c7-b6614f6f6e94
SPL ID 6ed14b8d-aba7-4096-bbab-81cf7aecb8a8
Version 3
Effective date 2019-11-07
Source export date 2026-09-28
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/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:51:43 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.