The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients (in each lozenge)Benzocaine 15 mgMenthol 3.6 mg
Otc - Purpose
PurposesOral anestheticOral anesthetic
Indications & Usage
Uses temporarily relieves these symptoms:
occasional minor irritation, pain, sore mouth and sore throat
- WarningsMethemoglobinemia 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)headacherapid heart rateshortness of breathdizziness or lightheadednessfatigue or lack of energySore 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. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.
- 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.
Otc - Do Not Use
- Do not usefor teethingin children under 2 years of age
Otc - Stop Use
- Stop use and ask doctor ifsore throat is severe or irritation, pain, or redness persists or worsenssore mouth symptoms do not improve in 7 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact Poison Control Center right away.
Dosage & Administration
Directionsadults and children 5 years and older - allow 1 lozenge to dissolve slowly in mouth. May be repeated every 2 hours as necessary or as directed by a doctorchildren under 5 years - do not use
Other Safety Information
- Other informationstore at room temperatureprotect from moisture
Inactive ingredients: Corn starch, FD&C red no. 40, glucose syrup, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.
Otc - Questions
Questions? Call 1-800-245-2898, Monday - Friday, 9AM to 4PM EST
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