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Menthol and Benzocaine and Dextromethorphan Hydrobromide

OTC Oral RxCUI 1045532
Contents

Overview

Active ingredient
Menthol, Benzocaine, Dextromethorphan Hydrobromide
Established class
Standardized Chemical Allergen
Physiologic effect
Increased Histamine Release; Cell-mediated Immunity
Chemical structure
Allergens
Route
Oral
Label date
2025-10-23

Indications and usage

Uses Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth cough due to minor throat and bronchial irritation as may occur with the common cold

Purpose

Oral pain reliever

Cough Suppressant

Oral pain reliever

Dosage and administration

Directions Adults and children over 12 years of age: 2 lozenges every 4 hours – not to exceed 12 lozenges every 24 hours. Children 6-12 years of age: 1 lozenge every 4 hours – not to exceed 6 lozenges every 24 hours. Children under 6 years of age: do not use.

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 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. If a skin reaction occurs, stop use and seek medical help right away. Sore Throat Warning : Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by a doctor. Do not use this product 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 are uncertain whether your prescription drug contains an MAOI, consult a health care professional before taking this product. for teething in children under 6 years of age Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, or emphysema a cough accompanied by excessive phlegm (mucus) When using this product do not exceed recommended dosage. Stop use and ask a dentist or doctor if: sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops cough persists for more than 1 week, tends to recur, or is accompanied by a high fever, rash, or persistent headache. These could be symptoms of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Do not use

this product 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 are uncertain whether your prescription drug contains an MAOI, consult a health care professional before taking this product. for teething in children under 6 years of age

Ask a doctor before use if

Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, or emphysema a cough accompanied by excessive phlegm (mucus)

When using this product

this product do not exceed recommended dosage.

Pregnancy or breast-feeding

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

Active ingredient (label)

s (in each lozenge) Benzocaine 6 mg

s (in each lozenge) Dextromethorphan HBr 5 mg

s (in each lozenge) Menthol 10 mg

Inactive ingredients

s Acesulfame Potassium, FD&C Blue no. 1, FD&C Red no. 40, Flavor, Glycerine, Hydrogenated Starch Hydrolysate, Isomalt, Soy Lecithin, Sucralose, Water

Keep out of reach of children

of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.