FDA label 58618c2b-b944-b310-e063-6394a90a38a4

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: 4c853456-51ef-abf3-e063-6394a90aa4ce
SPL ID: 58618c2b-b944-b310-e063-6394a90a38a4
Version: 3
Effective date: 2026-08-06
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:48:41

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		58618c2b-b944-b310-e063-6394a90a38a4	id
spl set id		4c853456-51ef-abf3-e063-6394a90aa4ce	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

If you are pregnant or breast-feeding, only use this medicine on the advice ofyour health care provider. smoking can seriously harm your child. Try to stopsmoking without using any nicotine replacement medicine. This medicine isbelieved to be safer than smoking. However, the risks to your child from thismedicine are not fully known.

Reported adverse events (FAERS/openFDA)#

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