Home FDA labels c54a5587-f6f9-4033-b84f-8f59e95e149f FDA label c54a5587-f6f9-4033-b84f-8f59e95e149f 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 62916efa-1ba5-4ce0-8607-1fc9f0cd536d
SPL ID c54a5587-f6f9-4033-b84f-8f59e95e149f
Version 2
Effective date 2012-04-02
Source export date 2026-11-06
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/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
Source manifest SHA-256 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run 20261108T063105Z
Imported at 2026-11-08 07:30:06 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 Warnings: If symptoms persist or worsen, or if pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children. Other: Tamper resistant for your protection. Use only if seal is intact. Reference image of pms relief.jpg
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.