FDA label cd2a84f0-e8e6-12f2-e053-2a95a90a70a4

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
ad66bad7-d3a6-0c8d-e053-2a95a90ab2f4
SPL ID
cd2a84f0-e8e6-12f2-e053-2a95a90a70a4
Version
2
Effective date
2021-09-29
Source export date
2026-08-01
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/0689a4374f1490600b5244071db3b04bd3bbc29ceda7a856edb8225323adf20a/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 22:59:59

Warnings cross-check#

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

Warnings sections page 1 of 1 · 3 matching rows.

warnings

Warnings Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serous condition that must be treated promptly because it reduces the amount of oygen 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" anesthetics. Sore throat warning: if sore throat is severe persists for more than 2 days, is accompanied or followed by high fever, headache, rash, nausea or vomiting, consult a doctor promptly. These may be serious. Do not use if you are taking a perscription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains as MAOI, asl a doctor or pharmacist before taking this product. do not use for teething in children under 2 years of age Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma or emphysema a cough that is accompanied by excessive phlegm (mucus0 Stop use and ask a doctor if a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or presistent headache. These could signs of a serious condiotion. Keep this and all drugs out of the reach of children. In case of an overdose, get medical help or contact Poison Control center right away.

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.

warnings

Sore throat warning: if sore throat is severe persists for more than 2 days, is accompanied or followed by high fever, headache, rash, nausea or vomiting, consult a doctor promptly. These may be serious.