FDA label 47461540-c155-bc33-e063-6394a90aaa9c

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
7c50d986-6a7b-425f-90a0-a60e21283bdf
SPL ID
47461540-c155-bc33-e063-6394a90aaa9c
Version
7
Effective date
2025-12-31
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:37:27

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: Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics. Sore throat warning: If sore throat is sever, persists for more than2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitings, consult a doctor promptly. Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persist or worsens. Do not exceed recommended dosage. When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor.

Reported adverse events (FAERS/openFDA)#

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