FDA label 193372ac-588b-6388-e063-6394a90a360c

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: 19336340-ad3d-62b7-e063-6294a90affed
SPL ID: 193372ac-588b-6388-e063-6394a90a360c
Version: 1
Effective date: 2024-05-17
Source export date: 2026-09-28
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/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:20:36

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		193372ac-588b-6388-e063-6394a90a360c	id
spl set id		19336340-ad3d-62b7-e063-6294a90affed	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 It you are pregnant or breast-feeding,only use this medicine on the advice of yourhealth care provider. Smoking can seriously harm your child.Try to stop smoking withou using any nicotine repiacement medicie.This medicineisbelieve(to be safer than smoking.However therisksto your childfrom this medicine are not fuly known

Reported adverse events (FAERS/openFDA)#

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