FDA label 0fa519d3-bf8c-a18b-e063-6294a90ab07b

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
83999f04-8d6e-4053-9d00-bf495b589fb0
SPL ID
0fa519d3-bf8c-a18b-e063-6294a90ab07b
Version
7
Effective date
2024-01-23
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:14:29

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: Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, nausea, and vomiting may be serious. Consult a dentist or doctor right away. Do not use more than 2 days or administer to children under 5 years of age unless directed by a doctor. When using this product do not exceed recommended dosage Stop Use and ask a doctor if sore throat is severe or irritation, pain or redness persists or worsens sore mouth symptom do not improve in 7 days If pregnant or breast-feeding, ask a health professional before use. Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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