FDA label f15a4fae-b01a-4016-8fe2-f99517e61ff5

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: a8a4449a-4e1f-4334-bc5b-2e0c82ac2592
SPL ID: f15a4fae-b01a-4016-8fe2-f99517e61ff5
Version: 1
Effective date: 2011-06-28
Source export date: 2026-11-06
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/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:29:45

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		f15a4fae-b01a-4016-8fe2-f99517e61ff5	id
spl set id		a8a4449a-4e1f-4334-bc5b-2e0c82ac2592	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 pregnant or breast-feeding, ask a health professional before use. Stop use and ask a doctor if symptoms continue or get worse, or new symptoms appear Keep our of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if safety seal around cap is broken or missing.

Reported adverse events (FAERS/openFDA)#

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