MIXED BERRY SORE THROAT AND COUGH LOZENGE- benzocaine lozenge 
Dollar General Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Benzocaine 7.5 mg
Dextromethorphan hydrobromide 5 mg

Active ingredients (in each lezenge)

Benzocaine 7.5 mg

Dextromethorphan hydrobromide 5 mg

Purpose

Oral pain reliever

Cough suppressant

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 a common cold

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 than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting contact 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 of doctor promptly.

Allergy alert: Do not use if you have a history of allergy to local anesthetics such as prociane, butacaine, benzocaine, or other "caine" anesthetics.

Do not use if you are now taking a prescription monoamineoxidase 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:

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

These could be signs of a serious illness.

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 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

Inactive ingredients: Acesulfame potassium, corn starch, corn syrup, FD&C blue no. 1, FD&C red no. 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 - Friday, 9AM to 4PM EST

Dollar General Mixed Berry Benx-Dex 18ct Throat Lozenges

MIXED BERRY SORE THROAT AND COUGH LOZENGE 
benzocaine lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-066
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:55910-066-1818 in 1 BLISTER PACK; Type 0: Not a Combination Product05/13/2016
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/13/2016
Labeler - Dollar General Corporation (068331990)
Registrant - Bestco Inc. (002149136)
Establishment
NameAddressID/FEIBusiness Operations
Bestco Inc002149136manufacture(55910-066)

Revised: 11/2021
Document Id: cfd41da8-5d13-9807-e053-2995a90a5827
Set id: 3d6fe13f-2dfb-3c80-e054-00144ff88e88
Version: 4
Effective Time: 20211102
 
Dollar General Corporation