FDA label 9c5a1b71-2df1-6752-e053-2a95a90abbc6

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
11eca6c7-03f0-26f0-e054-00144ff88e88
SPL ID
9c5a1b71-2df1-6752-e053-2a95a90abbc6
Version
3
Effective date
2024-01-17
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 05:20:47

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

USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN. • This product is intended to complement not replace standard smoking medical treatments. • Initial worsening of symptoms may occur. • If you are pregnant or breast-feeding, ask a health care professional before use. • Keep out of reach of children under the age of 12. Stop use and ask a doctor if: • New symptoms such as cough, congestion, allergies, and/or mouth, teeth or jaw problems occur.

Reported adverse events (FAERS/openFDA)#

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