FDA label b0b8413d-2d5b-4e27-a213-5573dd1e3e0d

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
5d49e61d-7bd1-4211-bbad-80da9d7dfabf
SPL ID
b0b8413d-2d5b-4e27-a213-5573dd1e3e0d
Version
2
Effective date
2018-08-09
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:00:43

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 According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms). 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. Keep out of reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.

Reported adverse events (FAERS/openFDA)#

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