FDA label 820a86f2-baa1-4cb0-8079-ae0f2a948eaa

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: 80a3941d-25bc-41c6-9475-b71a814af088
SPL ID: 820a86f2-baa1-4cb0-8079-ae0f2a948eaa
Version: 2
Effective date: 2011-05-10
Source export date: 2026-09-28
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:13:00

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		820a86f2-baa1-4cb0-8079-ae0f2a948eaa	id
spl set id		80a3941d-25bc-41c6-9475-b71a814af088	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 WARNINGS FOR RECTAL USE ONLY ASK A DOCTOR BEFORE USE IF YOU HAVE HEART DISEASE THYROID DISEASE HIGH BLOOD PRESSURE DIABETES TROUBLE URINATING DUE TO AN ENLARGED PROSTRATE GLAND ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE PRESENTLY TAKING A PRESCRIPTION DRUG FOR HIGH BLOOD PRESSURE OR DEPRESSION WHEN USING THIS PRODUCT DO NOT USE MORE THAN DIRECTED STOP USE AND ASK A DOCTOR IF SYMPTOMS GET WORSE OR DO NOT GET BETTER IN 7 DAYS BLEEDING OCCURS IF PREGNANT OR BREAST-FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE. TAMPER EVIDENT: DO NOT USE IF WRAPPER IS TORN OR OPENED

Reported adverse events (FAERS/openFDA)#

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