Home FDA labels c58572a8-5a4f-eb1b-e053-2995a90ae50e FDA label c58572a8-5a4f-eb1b-e053-2995a90ae50e 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 02467e89-c34e-4acf-bc93-2b02c4a86195
SPL ID c58572a8-5a4f-eb1b-e053-2995a90ae50e
Version 4
Effective date 2021-06-24
Source export date 2026-11-06
Source partition 5
Source file https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-11-06/bbdc0a42bf44145a63c3752991067bece7e2a518be6cc14943d33c4987faa012/drug-label-0005-of-0014.json.zip
Source manifest SHA-256 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run 20261108T063105Z
Imported at 2026-11-08 07:10:38 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 allergic to any ingredient. Contains lactose. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.