FDA label 33376694-fcce-6ed5-e054-00144ff8d46c

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
33378c59-fdf0-03fc-e054-00144ff8d46c
SPL ID
33376694-fcce-6ed5-e054-00144ff8d46c
Version
2
Effective date
2016-07-07
Source export date
2026-10-22
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/2026-10-22/e902d457a1761a44fd3a30c39db9aa876f06b0835423db5444f8d1a30fdfcfa1/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run
20261023T001338Z
Imported at
2026-10-23 01:36:23

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 Do not swallow. To avoid ingestion, supervision is required while children are using this product. Swallowing excessive amounts of fluoride could cause dental fluorosis. KEEP OUT OF REACH OF CHILDREN AND INFANTS.

Reported adverse events (FAERS/openFDA)#

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