FDA label a316010e-e242-46e3-b5d0-e56e0e63c80b

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
78bc8273-4daf-4be9-8686-7d2537382031
SPL ID
a316010e-e242-46e3-b5d0-e56e0e63c80b
Version
3
Effective date
2015-04-14
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:59:21

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 severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly. Do not use in a child under 5 years of age. Stop use and 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 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. Do not exceed recommended dosage.

Reported adverse events (FAERS/openFDA)#

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