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
2026-09-28
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/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:19:13

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.