FDA label 6c4af544-de64-4504-ae68-31b3e4d37c6d

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
5815a5e4-9b84-43bc-bbf3-4b85596e43d6
SPL ID
6c4af544-de64-4504-ae68-31b3e4d37c6d
Version
1
Effective date
2010-11-19
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:33:17

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.