Benzocaine 15 Mg
49b25e9e-1d47-4a10-e054-00144ff8d46c
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each lozenge) Benzocaine 15 mg Menthol 3.6 mg
Medication Information
Warnings and Precautions
Warnings
Methemoglobinemia warning:
Use of this product may cause methemoglobinemia, a serious conditin 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
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 . 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.
Indications and Usage
Uses temporarily relieves these symptoms:
occasional minor irritation, pain, sore mouth and sore throat
Dosage and Administration
Directions
adults 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 doctor.
children under 5 years - do not use
Description
Active ingredient (in each lozenge) Benzocaine 15 mg Menthol 3.6 mg
Section 34088-5
In case of overdose, get medical help or contact Poison Control Center right away.
Section 50565-1
Keep out of reach of children.
Section 50566-9
Stop use and ask doctor if
- sore throat is severe or irritation, pain or redness persists or worsens
- sore mouth symptoms do not improve in 7 days
Section 50570-1
Do not use
- for teething
- in children under 2 years of age
Section 51727-6
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.
Section 51945-4
Section 53413-1
Questions? Call 1-800-245-2898, Monday through Friday, 9AM to 4PM EST
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Purpose
Oral anesthetic
Oral anesthetic
Section 55106-9
Active ingredient (in each lozenge)
Benzocaine 15 mg
Menthol 3.6 mg
Section 60561-8
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.
Structured Label Content
Indications and Usage (34067-9)
Uses temporarily relieves these symptoms:
occasional minor irritation, pain, sore mouth and sore throat
Dosage and Administration (34068-7)
Directions
adults 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 doctor.
children under 5 years - do not use
Warnings and Precautions (34071-1)
Warnings
Methemoglobinemia warning:
Use of this product may cause methemoglobinemia, a serious conditin 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
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 . 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.
Section 34088-5 (34088-5)
In case of overdose, get medical help or contact Poison Control Center right away.
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 50566-9 (50566-9)
Stop use and ask doctor if
- sore throat is severe or irritation, pain or redness persists or worsens
- sore mouth symptoms do not improve in 7 days
Section 50570-1 (50570-1)
Do not use
- for teething
- in children under 2 years of age
Section 51727-6 (51727-6)
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.
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Questions? Call 1-800-245-2898, Monday through Friday, 9AM to 4PM EST
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Purpose
Oral anesthetic
Oral anesthetic
Section 55106-9 (55106-9)
Active ingredient (in each lozenge)
Benzocaine 15 mg
Menthol 3.6 mg
Section 60561-8 (60561-8)
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.
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:30.840715 · Updated: 2026-03-14T23:11:04.312793