FDA label 013ff1dc-e915-40bc-a6e7-b7ed86325be2

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: 8ed5792a-00d2-40b1-824b-488bde0bf2e0
SPL ID: 013ff1dc-e915-40bc-a6e7-b7ed86325be2
Version: 3
Effective date: 2026-05-13
Source export date: 2026-11-06
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/97001096994db9ca8cee114e6c3bb5298d3c573158ffc1ab8692d82e76a3eb40/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:55:51

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		013ff1dc-e915-40bc-a6e7-b7ed86325be2	id
spl set id		8ed5792a-00d2-40b1-824b-488bde0bf2e0	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: Do NOT use if you have ever had an allergic reaction to this product or any of its ingredients. Stop use and ask a doctor if your symptoms persist, worsen or new symptoms occur. Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away. If pregnant or breast feeding, ask a doctor before using product. Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken Store at room temperature and keep out of direct sunlight.

Reported adverse events (FAERS/openFDA)#

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