FDA.reportPublic FDA data

FDA label 174e6e47-3cf2-8cad-e063-6394a90aad57

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
174e6e47-3cf1-8cad-e063-6394a90aad57
SPL ID
174e6e47-3cf2-8cad-e063-6394a90aad57
Version
1
Effective date
2024-04-30
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:54:03

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 If pregnant or breast-feeding, ask a health professional before use. ______________________________ Keep out of reach of children. In case of ingestion call Poison Control Center hotline immediately at 1-800-222-1222. ______________________________ For external use only. ______________________________ When using this product ▪ do not use more than directed ______________________________ If symptoms persist more than 5 days, contact a licensed practitioner. ______________________________ Tamper Evident: Do not use product if tamper evident strip is broken. To report adverse events, contact MEDsan Inc. at 1-855-462-6334. Keep out of reach of children. In case of ingestion call Poison Control Center hotline immediately at 1-800-222-1222

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.