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Dextromethorphan Hydrobromide

OTC Oral RxCUI 1039251
Contents

Overview

Active ingredient
Benzocaine, Dextromethorphan Hydrobromide
Established class
Standardized Chemical Allergen
Physiologic effect
Increased Histamine Release; Cell-mediated Immunity
Chemical structure
Allergens
Route
Oral
Label date
2026-02-02

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

Purpose

Oral Pain Reliever Cough Suppressant

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

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.

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

Ask a doctor before use if

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)

Stop use and ask a doctor if

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

Overdosage

In case of overdose, get medical help or contact Poison Control Center right away.

Pregnancy or breast-feeding

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

Active ingredient (label)

s (in each lozenge) Benzocaine 7.5 mg Dextromethorphan hydrobromide 5 mg

Inactive ingredients

s: 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.

Storage and handling

Other information store at room temperature protect from moisture

Keep out of reach of children

of children.