FDA label 5b11c3df-36e7-41e9-bcca-08df6d2217d3

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: 33020ebb-fe2c-4489-86c6-fd30f1bf5cfc
SPL ID: 5b11c3df-36e7-41e9-bcca-08df6d2217d3
Version: 1
Effective date: 2012-10-31
Source export date: 2026-11-06
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/2026-11-06/d05434af5edc4383b7c7894a8f2d94df21171d17714450933cecdfc35cedfa3d/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:44:47

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		5b11c3df-36e7-41e9-bcca-08df6d2217d3	id
spl set id		33020ebb-fe2c-4489-86c6-fd30f1bf5cfc	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.

Reported adverse events (FAERS/openFDA)#

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