FDA label 69de53ed-6797-4976-946a-4a741f88ea90

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
00c68fa6-ae49-4b73-bb71-5e960dc98368
SPL ID
69de53ed-6797-4976-946a-4a741f88ea90
Version
2
Effective date
2013-05-17
Source export date
2026-10-12
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/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:33:55

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

5 WARNINGS AND PRECAUTIONS DO NOT SWALLOW. Ingestion of high levels of fluoride may cause abdominal pain, weakness, tremor, spasm, or convulsions. There have been no long term studies with this product to evaluate carcinogenic, mutagenic or impairment of fertility potential. DO NOT SWALLOW. ( 5 ) Ingestion of high levels of fluoride may cause abdominal pain, weakness, tremor, spasm, or convulsions. ( 5 )

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

6 ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported. Developing teeth of children under age 6 may become permanently discolored if excessive amounts of fluoride are repeatedly swallowed. Allergic reactions and other idiosyncrasies have been rarely reported. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact 3M ESPE Dental Products Division at 1-800-634-2249 or www.3MESPE.com , or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Reported adverse events (FAERS/openFDA)#

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