FDA.reportPublic FDA data

FDA label 79fcc2ea-76bb-4b93-a844-ca3c83ef0402

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
f546e13d-e535-49ba-9169-cfc4ee6a6775
SPL ID
79fcc2ea-76bb-4b93-a844-ca3c83ef0402
Version
2
Effective date
2014-09-15
Source export date
2026-11-06
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/2026-11-06/968b7138703f8100b14008bced2b2a4531f4fab250b207279e9c05eb19608f40/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run
20261106T075659Z
Imported at
2026-11-06 08:16:12

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: Initial exacerbation of symptoms may occur. Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops, see your dentist or doctor promptly. Do not exceed recommended dosage. As with all medications, it is important to ensure that your child’s medical professional is aware of the use of this product.

Reported adverse events (FAERS/openFDA)#

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