FDA label 371d4ba3-420a-412c-ad8a-d88aa68c0d5b

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
3ef75f3c-cc00-4b39-9249-161da76bb9a7
SPL ID
371d4ba3-420a-412c-ad8a-d88aa68c0d5b
Version
2
Effective date
2018-11-22
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:33:37

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 Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you, or a child in your care develops: • Pale gray, or blue colored skin (cyanosis) • Headache • Rapid heart rate • Shortness of breath • Dizziness or lightheadedness • Fatigue or lack of energy 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" anesthetic. If skin reaction occurs, stop use and seek medical help right away. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly Do not use (unless directed by a doctor): • more than directed • for more than 7 days • in children under 2 years of age • for teething. Stop use and see a doctor promptly if: • sore mouth symptoms do not improve in 7 days • irritation, pain or redness persist or worsen • swelling, rash or fever develops. If pregnant or breast-feeding, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. If swallowed, 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.