Benzocaine 15 Mg

Benzocaine 15 Mg
SPL v8
SPL
SPL Set ID 60b876e7-c642-5ce8-e053-2a91aa0abd6e
Route
ORAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3.6 mg) Benzocaine (15 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Pill Appearance
Imprint: B Shape: round Color: red Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-19

Description

Active ingredients (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 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)
  • hearache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Sore throat warning: If sore throat is severe, persistent 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 persist 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.

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 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 #40, glucose syrup, glycerin, medium chain triglycerides, natural & artificial flavors, propylene glycol, soybean oil, sucrose and water.

Section 51945-4

Section 53413-1

Questions? Or to report an adverse event call 1-888-423-0139.

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 ingredients (in each lozenge)

Benzocaine 15 mg

Menthol 3.6 mg

Section 60561-8

Other information

store at room temperature

protect from moisture


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 two 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 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)
  • hearache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Sore throat warning: If sore throat is severe, persistent 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 persist 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.

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 #40, glucose syrup, glycerin, medium chain triglycerides, natural & artificial flavors, propylene glycol, soybean oil, sucrose and water.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Or to report an adverse event call 1-888-423-0139.

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 ingredients (in each lozenge)

Benzocaine 15 mg

Menthol 3.6 mg

Section 60561-8 (60561-8)

Other information

store at room temperature

protect from moisture


Advanced Ingredient Data


Raw Label Data

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