Leader Mixed Berry Benz-Dex Lozenges

Manufacturer
Cardinal Health | Bestco LLC
Effective date
2024-12-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:48:08

Label at a glance#

ProductLeader Mixed Berry Benz-Dex Lozenges
Active ingredientBENZOCAINE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each lozenge)

Benzocaine 7.5 mg

Dextromethorphan hydrobromide 5 mg

OTC - PURPOSE SECTION

Proposes

Oral Pain Reliever

Cough Suppressant

INDICATIONS & USAGE SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Mixed Berry Benz-Dex 18ct LozengesLeader Mixed Berry Benz-Dex 18ct Lozenges

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0552LEADER MIXED BERRY BENZ-DEX LOZENGES (BENZOCAINE) LOZENGE [CARDINAL HEALTH]4Legacy NDC20241203_a79890fd-e49e-03db-e053-2995a90a6292.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-055270000-0552-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4561d29d-ddb1-d27d-e063-6394a90abe10a79890fd-e49e-03db-e053-2995a90a62922025-12-07WarningsExact identifier
spl set id: a79890fd-e49e-03db-e053-2995a90a6292

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.