FDA label 315d7a68-4823-4169-aca1-25ec89a2fdd3

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
0f4dae93-2e42-4815-be2f-ff4887a8fd5f
SPL ID
315d7a68-4823-4169-aca1-25ec89a2fdd3
Version
6
Effective date
2024-11-20
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 01:32:49

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: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days. When using this product, do not exceed recommended dose. Stop use and ask a dentist or doctor if sore throat is severe, or last for more than 2 days sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsen fever, headache, rash, swelling, nausea or vomiting develops If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If more than used for minor mouth or throat pain is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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