FDA label 45b0adb0-7f48-81a3-e063-6294a90ad09a

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: e20b7cc8-5682-4e66-b5d5-5fa1035c0b77
SPL ID: 45b0adb0-7f48-81a3-e063-6294a90ad09a
Version: 118
Effective date: 2025-12-11
Source export date: 2026-09-28
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/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:25:35

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		45b0adb0-7f48-81a3-e063-6294a90ad09a	id
spl set id		e20b7cc8-5682-4e66-b5d5-5fa1035c0b77	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

WARNINGS: • DO NOT SWALLOW . An occasional accidental ingestion of a usual treatment dose (a thin ribbon) is harmless. If more than used for treatment is swallowed, administer calcium (e.g. milk) and get medical help or contact a Poison Control Center right away. • Keep out of the reach of infants and children under 12 years. • Children under 12 years should use this product only under adult supervision to prevent swallowing. Safety and effectiveness below age 6 have not been established.

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: Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache and weakness. In patients with mucositis, gingival tissues may be hypersensitive to the flavor.

Reported adverse events (FAERS/openFDA)#

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