LEADER MIXED BERRY BENZ-DEX LOZENGES- benzocaine lozenge 
Cardinal Health

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Benzocaine 7.5 mg
Dextromethorphan hydrobromide 5 mg

Active ingredients (in each lozenge)

Benzocaine 7.5 mg

Dextromethorphan hydrobromide 5 mg

Proposes

Oral Pain Reliever

Cough Suppressant

Uses temporarily relieves these symptoms:

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:

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.

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.

Ask a doctor before use if you have:

Stop use and ask a doctor if

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

Keep out of reach of children.

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

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 information

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.

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

Leader Mixed Berry Benz-Dex 18ct Lozenges

LEADER MIXED BERRY BENZ-DEX LOZENGES 
benzocaine lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0552
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7.5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorred (Purplish Red) Scoreno score
ShapeROUNDSize17mm
FlavorBERRYImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0552-118 in 1 BLISTER PACK; Type 0: Not a Combination Product06/08/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/08/2020
Labeler - Cardinal Health (063997360)
Registrant - Bestco LLC (002149136)
Establishment
NameAddressID/FEIBusiness Operations
Bestco LLC002149136manufacture(70000-0552)

Revised: 10/2023
Document Id: 081793ca-59e6-86cb-e063-6394a90a9d39
Set id: a79890fd-e49e-03db-e053-2995a90a6292
Version: 3
Effective Time: 20231019
 
Cardinal Health