FDA.reportPublic FDA data

FDA label 307c4797-e3c6-46c1-b950-36014bd3d927

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
88fa8d66-86d3-40c2-a6f7-b29ec2f060e8
SPL ID
307c4797-e3c6-46c1-b950-36014bd3d927
Version
11
Effective date
2018-12-14
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:10:53

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

Warning: Keep out of reach of children. Do not swallow. If swallowed during treatment, administer milk, limewater, or antacid. If larger dose is ingested (more than 1/4 ounce), contact poison control and immediately seek medical help. Do not use in patients with an allergy to fluoride.

Adverse reactions cross-check#

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

adverse reactions

Adverse reactions: Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. Individuals hypersensitive to fluoride may have an adverse reaction.

Reported adverse events (FAERS/openFDA)#

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