FDA label 025a45e6-c192-f848-e063-6394a90a1e29

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
1410fa91-d1bc-4797-b888-9b6971f643e0
SPL ID
025a45e6-c192-f848-e063-6394a90a1e29
Version
10
Effective date
2023-08-07
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:44:01

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 mthemoglobinemia, a serious condition that must be treated promptyly because it reduces the amount of oxygen carried in the 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 enegry Allegry alert do not use this product if you have a history of allergy to local anesthetics such as prcaine, butacaine, bezocaine, or other "caine" anesthetics. Alcogol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whehter you should take slicylic acid or other pain reliever, fever reducer. Salicylic acid may cause stomach bleeding. Flammable: Keep away from fire or flame. Do not use for teething in children under 2 years of age When using this prduct Do not use near eyes. Do not prolong usage unless directed by a doctor/dentist. Stop use and ask a doctor promptly if sore mouth symptoms do not improve in 7 days or if irritation, pain or redness persists or worsens. If you sore throat is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.