Benzocaine 7.5mg

Benzocaine 7.5mg
SPL v8
SPL
SPL Set ID 304ff4db-201a-60a4-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2026-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (7.5 mg) Dextromethorphan (5 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 2016-04-12

Description

Active ingredients (in each lozenge) Benzocaine 7.5 mg Dextromethorphan hydrobromide 5 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)
  • 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.

Indications and Usage

Uses temporarily relieves these symptoms:

occasional minor mouth irritation, sore mouth and sore throat

cough due to minor throat and bronchial irritationas may occur with a common cold

Dosage and Administration

Directions

adults and children 12 years and older: Allow 2 lozenages to dissolve slowly in mouth, one at a time. May be repeated every 4 hours, not to exceed 12 lozenges in 24 hours, or as directed by a doctor

children 6 to 12 years of age: take1 lozenge and allow to dissolve slowly in the mouth. May be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor

children under 6 years of age: do not use

Description

Active ingredients (in each lozenge) Benzocaine 7.5 mg Dextromethorphan hydrobromide 5 mg

Section 34088-5

In case of overdose, get medical help or contact 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 mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling develops
  • cough lasts more than 7 days, comes back, or occurs with feaver, rash, or persistent headache. These could be signs of a serious illness
Section 50569-3

Ask a doctor before use if you have:

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
Section 50570-1

Do not use if you are now taking a presciption monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • for teeting
  • in children under 2 years of age
Section 51727-6

Inactive ingredients: Acesulfame potassium, corn starch, corn syrup, FD&C blue 1, FD&C red 40, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.

Section 51945-4

Section 53413-1

Questions? or to report an adverse event 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 Pain Reliever

Cough Suppressant

Section 55106-9

Active ingredients (in each lozenge)

Benzocaine 7.5 mg

Dextromethorphan hydrobromide 5 mg


Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves these symptoms:

occasional minor mouth irritation, sore mouth and sore throat

cough due to minor throat and bronchial irritationas may occur with a common cold

Dosage and Administration (34068-7)

Directions

adults and children 12 years and older: Allow 2 lozenages to dissolve slowly in mouth, one at a time. May be repeated every 4 hours, not to exceed 12 lozenges in 24 hours, or as directed by a doctor

children 6 to 12 years of age: take1 lozenge and allow to dissolve slowly in the mouth. May be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor

children under 6 years of age: 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)
  • 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.

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact 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 mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling develops
  • cough lasts more than 7 days, comes back, or occurs with feaver, rash, or persistent headache. These could be signs of a serious illness
Section 50569-3 (50569-3)

Ask a doctor before use if you have:

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
Section 50570-1 (50570-1)

Do not use if you are now taking a presciption monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • for teeting
  • in children under 2 years of age
Section 51727-6 (51727-6)

Inactive ingredients: Acesulfame potassium, corn starch, corn syrup, FD&C blue 1, FD&C red 40, 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? or to report an adverse event 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 Pain Reliever

Cough Suppressant

Section 55106-9 (55106-9)

Active ingredients (in each lozenge)

Benzocaine 7.5 mg

Dextromethorphan hydrobromide 5 mg


Advanced Ingredient Data


Raw Label Data

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