Benzocaine 7.5mg
304ff4db-201a-60a4-e054-00144ff8d46c
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:08:29.711620 · Updated: 2026-03-14T23:12:44.067976