FDA label 5b0eb13b-dd89-d7b2-e063-6294a90ae29c

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: 92e69995-3eeb-4810-9639-c0246bacc7ac
SPL ID: 5b0eb13b-dd89-d7b2-e063-6294a90ae29c
Version: 4
Effective date: 2026-09-09
Source export date: 2026-10-23
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/2026-10-23/66f0738d1e9df36d14d772c3e478041aa60576202356874a08629ca00a75c0e2/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 003b0607e7bf4d3ce17ccc0942e221303b4f62b17a6a00c54547eda454293380
Import run: 20261026T035824Z
Imported at: 2026-10-26 04:18:52

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		5b0eb13b-dd89-d7b2-e063-6294a90ae29c	id
spl set id		92e69995-3eeb-4810-9639-c0246bacc7ac	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.