FDA label 3c4ebd80-4f5a-4478-9c9e-554510331cc4

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: 4f63d49c-dfa8-482d-bb8b-574ec2ba0289
SPL ID: 3c4ebd80-4f5a-4478-9c9e-554510331cc4
Version: 6
Effective date: 2025-01-17
Source export date: 2026-11-06
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/2026-11-06/97001096994db9ca8cee114e6c3bb5298d3c573158ffc1ab8692d82e76a3eb40/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:56:55

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		3c4ebd80-4f5a-4478-9c9e-554510331cc4	id
spl set id		4f63d49c-dfa8-482d-bb8b-574ec2ba0289	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 Sore throat warning : if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if : sore mouth does not improve in 7 days irritation, pain or redness persists or worsens Keep out of reach of children .

Reported adverse events (FAERS/openFDA)#

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