Purpose
Benzocaine 6 mg......................................................... Oral pain reliever
Dextromethorphan HBr 5 mg .…………………………..Cough suppressant
Menthol 10 mg……………………………,…….………. Oral pain reliever
The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc for the product Diabetic Tussin Sore Throat And Cough Cherry (NDC 61787-070). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a dentist or doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Benzocaine 6 mg......................................................... Oral pain reliever
Dextromethorphan HBr 5 mg .…………………………..Cough suppressant
Menthol 10 mg……………………………,…….………. Oral pain reliever
Temporarily relieves:
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” anesthetics. If a skin reaction occurs, stop use and seek medical help right away.
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 give to children under 6 years of age unless directed by a doctor.
do not exceed recommended dosage.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
acesulfame potassium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, hydrogenated starch hydrolysate, isomalt, soy lecithin, sucralose, water
1-800-579-8327 http://diabetictussin.com
Diabetic Tussin® Sore Throat & Cough Lozenges
Menthol/Benzocaine Oral Pain Relievers Dextromethorphan HBr/Cough Suppressant
Wild cherry 15 lozenges
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