FDA label 0df98075-28f5-86ac-e063-6394a90a5d42

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: b57daec8-368c-6b59-e053-2a95a90a4510
SPL ID: 0df98075-28f5-86ac-e063-6394a90a5d42
Version: 2
Effective date: 2024-01-02
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:03:03

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		0df98075-28f5-86ac-e063-6394a90a5d42	id
spl set id		b57daec8-368c-6b59-e053-2a95a90a4510	set_id

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 If condition worsens or does not improve within 7 days, consult a doctor. Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Certain persons can develop allergic reactions to ingredients in this product. If symptoms being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increases, discontinue use and consult a doctor.

Reported adverse events (FAERS/openFDA)#

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