FDA label 4e7a3618-3d32-4b77-8a3e-023d4eb65ee6

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: 4a6c9e2d-58a3-4831-876c-644af778bdf6
SPL ID: 4e7a3618-3d32-4b77-8a3e-023d4eb65ee6
Version: 13
Effective date: 2010-06-30
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:51:20

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		4e7a3618-3d32-4b77-8a3e-023d4eb65ee6	id
spl set id		4a6c9e2d-58a3-4831-876c-644af778bdf6	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, accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentist or doctor promptly. Do not exceed recommended dosage. If pregnant or breastfeeding, ask a health professional before use. Keep this and all drugs out of the reach of children.

Reported adverse events (FAERS/openFDA)#

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