FDA label 5a25e932-9e3b-4075-8465-e8c7cad04fa4

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
c18b2b07-b2ff-41d0-bd87-cb9e33838aa4
SPL ID
5a25e932-9e3b-4075-8465-e8c7cad04fa4
Version
3
Effective date
2019-07-26
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:28

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 or administer to children under 6 years of age unless directed by a doctor. When using this product do not exceed recommended dosage. Stop Useand ask a doctor or dentist if sore mouth symptoms do not improve in 7 days● irritation, pain or redness persists or worsens ●swelling, rash or fever develops If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. In case of overdose, or accidental poisoning, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Reported adverse events (FAERS/openFDA)#

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