FDA label 6fcad18d-eecd-2278-e053-2991aa0a8024

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
567bf599-4958-91c7-5c01-9c38a0d2da52
SPL ID
6fcad18d-eecd-2278-e053-2991aa0a8024
Version
7
Effective date
2018-06-29
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:30:28

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Stop use and ask a doctor if: Sore mouth symptoms do not improve in 7 days. Swelling, rash or fever develops. Irritation, pain or redness persists of worsens.

warnings

Warnings Stop use and ask a dentist if: Gingivitis, bleeding or redness persists for more than 2 weeks. You have painful or swollen gums, pus from the gum line, loose teeth or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Reported adverse events (FAERS/openFDA)#

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