FDA Label for Leader Mixed Berry Benz-dex Lozenges

Otc - Active Ingredient

Active ingredients (in each lozenge)

Benzocaine 7.5 mg

Dextromethorphan hydrobromide 5 mg

Otc - Purpose

Proposes

Oral Pain Reliever

Cough Suppressant

Indications & 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

Warnings

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
• repid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

Sore throat warning: If sore throat is severe, persists for more then 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.

Otc - Do Not Use

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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

• for teething
• in children under 2 years of age

Otc - Ask Doctor

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)

Otc - Stop Use

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, come back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illiness.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

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

Dosage & 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 the mouth; may be repeated every 4 hours, not to exceed 6 logenges in 24 hours, or as directed by a doctor

children under 6 years of age - do not use

Other Safety Information

Other information

• store at room temperature
• protect from moisture

Inactive Ingredient

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.

Otc - Questions

Questions? Or to report an adverse event call 1-800-245-2898, Monday through Friday, 9AM - 4PM EST