FDA label 049e609b-4ef5-c302-e063-6394a90ac2ce

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: 63b0de92-d0fb-4909-b3ae-145316ff4b51
SPL ID: 049e609b-4ef5-c302-e063-6394a90ac2ce
Version: 3
Effective date: 2023-09-05
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:43:27

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.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		049e609b-4ef5-c302-e063-6394a90ac2ce	id
spl set id		63b0de92-d0fb-4909-b3ae-145316ff4b51	set_id

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. This product should not be used by individuals with milk allergies.

Reported adverse events (FAERS/openFDA)#

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