Benzocaine 7.5 Mg

Benzocaine 7.5 Mg
SPL v5
SPL
SPL Set ID c0a6cb7f-a247-e610-e053-2a95a90a4199
Route
ORAL
Published
Effective Date 2025-12-01
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 2021-04-23

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 threat 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 persist or worsens, see your dentist or doctor promptly.

Indications and Usage

Uses temporarily relieves these symptoms:

  • occasional minor mouth irritation, sore mouth and sore throat
  • cough due to minor throat and bronchial irritation as may occur with the common cold
Dosage and Administration

Directions

adults and children 12 years and older - Allow 2 lozenges 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 - take 1 lozenge and allow to dissolve slowly in 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 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask 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 fever, 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 accurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
Section 50570-1

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.

Do not use if you are now taking a prescription 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 you prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • for teething
  • 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? 1-888-287-1915

Section 53414-9

If pregnant of breast-feeding, ask a health professional before use.

Section 55105-1

Purposes

Oral Pain Reliever

Cough Suppressant

Section 55106-9

Active ingredients (in each lozenge)

Benzocaine 7.5 mg

Dextromethorphan hydrobromide 5 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 mouth irritation, sore mouth and sore throat
  • cough due to minor throat and bronchial irritation as may occur with the common cold
Dosage and Administration (34068-7)

Directions

adults and children 12 years and older - Allow 2 lozenges 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 - take 1 lozenge and allow to dissolve slowly in 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 threat 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 persist 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 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 fever, 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 accurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
Section 50570-1 (50570-1)

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.

Do not use if you are now taking a prescription 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 you prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • for teething
  • 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? 1-888-287-1915

Section 53414-9 (53414-9)

If pregnant of breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purposes

Oral Pain Reliever

Cough Suppressant

Section 55106-9 (55106-9)

Active ingredients (in each lozenge)

Benzocaine 7.5 mg

Dextromethorphan hydrobromide 5 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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