FDA.reportPublic FDA data

FDA label 701603fa-bf1b-111c-e053-2991aa0ae2b4

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
71fcb372-0dec-423e-ab77-071ea690feb5
SPL ID
701603fa-bf1b-111c-e053-2991aa0ae2b4
Version
3
Effective date
2018-07-03
Source export date
2026-08-01
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/2026-08-01/206e0852f7011b53c21719ec5c68ac6752381d0fcd1d348f7428adad64429e89/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:17:07

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 For rectal use only. When using this product do not exceed the recommended daily dosage unless directed by doctor. Stop use and consult a doctor if: condition worsens or does not improve within 7 days the introduction of the applicator into the rectum causes additional pain or bleeding occurs If pregnant or breastfeeding, consult a health care professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.