FDA label 9c5a15eb-7861-6750-e053-2a95a90a57ed

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
11e8fe93-8f88-473a-e054-00144ff88e88
SPL ID
9c5a15eb-7861-6750-e053-2a95a90a57ed
Version
2
Effective date
2024-11-17
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:52:41

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. • 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.