Home FDA labels 63c9e161-983f-4d55-9df2-9e93152a29bd FDA label 63c9e161-983f-4d55-9df2-9e93152a29bd 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 c3f91ca2-6e60-4ac9-8fc3-706882b591b0
SPL ID 63c9e161-983f-4d55-9df2-9e93152a29bd
Version 4
Effective date 2021-03-02
Source export date 2026-11-06
Source partition 4
Source file https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-11-06/b00a73f24c6ff050408c570063640e3d80d1f71dfc9a165d1cf072a25659445a/drug-label-0004-of-0014.json.zip
Source manifest SHA-256 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run 20261108T063105Z
Imported at 2026-11-08 07:00:04 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
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 the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Caution: Do not eat or drink dairy products within one hour of fluoride administration. Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.