FDA label f434ffc9-23c8-4ee9-bf9d-d80a08136dbe

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
d6c29a96-af79-41e9-84b3-e38b6ff70f85
SPL ID
f434ffc9-23c8-4ee9-bf9d-d80a08136dbe
Version
3
Effective date
2010-11-19
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:51:02

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 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 more than 2 days or administer to children under 6 years of age unless directed by a doctor. When using this product: do not exceed recommended dosage. Stop use and ask a dentist or doctor 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 care professional before use. Keep out of reach of children. In case of overdose or accidental poisoning, 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.