FDA label 48c92305-60a3-1a95-e063-6394a90a13cd

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: 3860be04-7e36-2eae-e063-6394a90a765e
SPL ID: 48c92305-60a3-1a95-e063-6394a90a13cd
Version: 2
Effective date: 2026-01-19
Source export date: 2026-10-12
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:31:57

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		48c92305-60a3-1a95-e063-6394a90a13cd	id
spl set id		3860be04-7e36-2eae-e063-6394a90a765e	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 use ifyou are allergic to any ingredient in this product or in children under 12 without dentaladvice ●When using this product, do not swallow, avoid contact witheyes. If contact occurs, rinse thoroughlywith water. ●Stop use and ask a doctor firritation, swelling,or rashdevelops. ●Keep out of reach of children. If swallowed, immediatelyseek medical help or contact a PoisonControl Center right away.

Reported adverse events (FAERS/openFDA)#

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