FDA.reportPublic FDA data

FDA label 3e73d56c-e47f-93b6-e063-6294a90a9ccd

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
3e73e9b0-61b0-fe4a-e063-6394a90a7132
SPL ID
3e73d56c-e47f-93b6-e063-6294a90a9ccd
Version
1
Effective date
2025-09-10
Source export date
2026-08-01
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/2026-08-01/f23e8214fa581dc87bce024b3f15739356a8bb6f9298e3d6be38c21c662a4211/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:07:59

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 If you are pregnant or breast-feeding, only use thismedicine on the advice of your health care provider.Smoking can seriously harm your child. Try to stopsmoking without using any nicotine replacementmedicine,This medicine is believed to be safer thansmoking.However, the risks to your child from thismedicine are not fully known.