FDA label 6b3e56d0-60cb-713b-e053-2991aa0a2d19

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
a79262c6-9865-426e-96cb-c790854d0134
SPL ID
6b3e56d0-60cb-713b-e053-2991aa0a2d19
Version
5
Effective date
2018-05-02
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:12:57

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 or 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 gum, 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.