FDA label 9f705a1c-3f0b-4475-892a-71eb7be9640f

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
bbbb6557-975a-44c5-882a-1aba48e7b055
SPL ID
9f705a1c-3f0b-4475-892a-71eb7be9640f
Version
3
Effective date
2017-02-27
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:31:08

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 4 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, nausea, and 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 sore mouth 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.

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, nausea, and 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 sore mouth 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.

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, nausea, and 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 sore mouth 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.

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, nausea, and 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 sore mouth 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.