FDA.reportPublic FDA data

FDA label 5efe5fb6-a7f9-17cf-e053-2991aa0a31a2

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
11c10a77-79d4-2509-e054-00144ff88e88
SPL ID
5efe5fb6-a7f9-17cf-e053-2991aa0a31a2
Version
2
Effective date
2017-11-27
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:58:53

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 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. Pregnancy or Breast Feeding • 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 • Keep out of reach of children under the age of 12. Stop use and ask a doctor if: Stop use and ask a doctor if: • New symptoms such as cough, congestion, allergies, and/or mouth, teeth or jaw problems occur. In case of overdose • In case of overdose get medical help or contact a poison control center right away.

Reported adverse events (FAERS/openFDA)#

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