FDA label 8c3fcbfc-425c-4ba0-b14a-23d8cb83008a

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: 51dd7b9a-ce98-41ea-ade8-3d8d6d67f91a
SPL ID: 8c3fcbfc-425c-4ba0-b14a-23d8cb83008a
Version: 3
Effective date: 2020-05-26
Source export date: 2026-11-06
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/b00a73f24c6ff050408c570063640e3d80d1f71dfc9a165d1cf072a25659445a/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:59:55

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		8c3fcbfc-425c-4ba0-b14a-23d8cb83008a	id
spl set id		51dd7b9a-ce98-41ea-ade8-3d8d6d67f91a	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

WARNING: Consult a physician for use in children under 12 years of age. IF PREGNANT OR BREAST-FEEDING , ask a health care professional before use. KEEP OUT OF THE REACH OF CHILDREN . In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away. Do not use if TAMPER EVIDENT seal is broken or missing.

Reported adverse events (FAERS/openFDA)#

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