FDA.reportPublic FDA data

FDA label 16da5360-6f0d-e061-e063-6394a90a3890

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
16da5360-6f0c-e061-e063-6394a90a3890
SPL ID
16da5360-6f0d-e061-e063-6394a90a3890
Version
1
Effective date
2024-04-25
Source export date
2026-11-06
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:55:09

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

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 rectal 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: Use this product only if inner blister pack is intact. 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.