menthol 3.6mg

Drug Facts

Composition & Product

Active Ingredients

benzocaine (15 mg) menthol (3.6 mg)

Inactive Ingredients

sucrose

Identifiers & Packaging

Pill Appearance

Imprint: B Shape: round Color: red Size: 17 mm

Marketing Status

otc monograph drug active Since 2016-04-01

Medication Information

Warnings and Precautions

Warnings

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

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.

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.

Active Ingredient

Active Ingredients (in each lozenge)

Benzocaine 15mg

Menthol 3.6mg

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 two hours as necessary or as directed by a doctor

children under 5 years - do not use

Description

Active Ingredients (in each lozenge) Benzocaine 15mg Menthol 3.6mg

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 44425-7

Other information

store at room temperature
protect from moisture

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

sore throat is severe or irritation, pain or redness persists or worsens
sore mouth symptoms do not improve is 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 #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 - 4PM EST

Section 53414-9

If Pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Oral anesthetic

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

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

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.

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.

Active Ingredient (55106-9)

Active Ingredients (in each lozenge)

Benzocaine 15mg

Menthol 3.6mg

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 two hours as necessary or as directed by a doctor

children under 5 years - do not use

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 44425-7 (44425-7)

Other information

store at room temperature
protect from moisture

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

sore throat is severe or irritation, pain or redness persists or worsens
sore mouth symptoms do not improve is 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 #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 - 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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses - temporarily relieves these symptoms occasional minor irritation, pain, sore mouth and sore throat", "34068-7": "Directions adults and children 5 years and older - allow 1 lozenge to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor children under 5 years - do not use", "34071-1": "Warnings 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 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. 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.", "34088-5": "In case of overdose, get medical help or contact a Poison Control Center right away.", "44425-7": "Other information store at room temperature protect from moisture", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor if sore throat is severe or irritation, pain or redness persists or worsens sore mouth symptoms do not improve is 7 days", "50570-1": "Do not use for teething in children under 2 years of age", "51727-6": "Inactive Ingredients Corn starch, FD&C red #40, glucose syrup, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose, and water.", "53413-1": "Questions? Call 1-800-245-2898 , Monday through Friday, 9AM - 4PM EST", "53414-9": "If Pregnant or breast-feeding , ask a health professional before use.", "55105-1": "Purpose Oral anesthetic Oral anesthetic", "55106-9": "Active Ingredients (in each lozenge) Benzocaine 15mg Menthol 3.6mg"}