FDA label 6785c09c-fa71-4326-a4eb-0e60def6e31e

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: 8c46adfd-7b74-41ee-ae0a-565df512734e
SPL ID: 6785c09c-fa71-4326-a4eb-0e60def6e31e
Version: 2
Effective date: 2025-08-14
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:54:09

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		6785c09c-fa71-4326-a4eb-0e60def6e31e	id
spl set id		8c46adfd-7b74-41ee-ae0a-565df512734e	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 • Ask a doctor before use in children under 12 years of age. • Stop use and ask a doctor if symptoms persist for more than 3 days or worsen. • If pregnant or breastfeeding , consult your health professional before use. • Keep out of reach of children. • Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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