FDA.reportPublic FDA data

FDA label f1efdbd0-82bd-bc19-e053-2a95a90ac533

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
67c7c647-a3a8-2d4d-e053-2a91aa0aea94
SPL ID
f1efdbd0-82bd-bc19-e053-2a95a90ac533
Version
5
Effective date
2023-01-10
Source export date
2026-08-01
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/5a565ce64c898c83223b815b9579cd46fb0c6d54977c3cace2133e40124f7fbb/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:09:39

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 external use only Allergy alert: Certain persons can develop allergic reactions to ingredients in this product Stop use and ask a doctor if: condition worsens or does not improve within 7 days rectal bleeding occurs an allergic reaction develops the symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breastfeeding , ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.