FDA label bf5e0afe-a6a5-4e9c-be8a-12cb8c5de14a

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
037b6805-6722-4ab7-8862-409407a5fea5
SPL ID
bf5e0afe-a6a5-4e9c-be8a-12cb8c5de14a
Version
1
Effective date
2014-10-06
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:23:04

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings For rectal use only

warnings and cautions

When using this product your child When using this product your child may have rectal discomfort or a burning sensation.

Reported adverse events (FAERS/openFDA)#

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