FDA label 1c7b4c81-8ad6-4b85-911c-103afd887c63

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
a0e52795-e4ec-4205-8862-a51a2b2a7ae1
SPL ID
1c7b4c81-8ad6-4b85-911c-103afd887c63
Version
3
Effective date
2017-02-27
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 01:29:48

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 t hroat w arning Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, nausea or vomiting may be serious. Consult a doctor promptly. Do not use for more than 2 days or give to children under 5 years of age. Stop use and ask a doctor if symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens. If pregnant or breast feeding ask a health professional before use. Keep this and all drugs out of 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.