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Mixed Berry Sore Throat and Cough lozenge

Medically reviewed on April 12, 2018

Dosage form: lozenge
Ingredients: BENZOCAINE 7.5mg, DEXTROMETHORPHAN HYDROBROMIDE 5mg
Labeler: Meijer Distribution, Inc.
NDC Code: 41250-066

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.

Benzocaine 7.5mg
Dextromethorphan Hydrobromide 5mg

Active ingredients (in each lozenge)

Benzocaine 7.5 mg

Dextromethorphan hydrobromide 5 mg

Purpose

Oral Pain Reliever

Cough Suppressant

Warnings

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 consult a 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.

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

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

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

Keep out of reach of children.

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

Store at room temperature

Protect from moisture

Inactive ingredients: Acesulfame potassium, corn starch, corn syrup, glycerine, FD&C blue 1, FD&C red 40, natural and artificial flavors, medium chain triglycerides, 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

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

MIXED BERRY SORE THROAT AND COUGH LOZENGE 
dextromethorphan hydrobromide lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-066
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE7.5 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
Product Characteristics
Colorred (purplish red) Scoreno score
ShapeROUNDSize17mm
FlavorBERRYImprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:41250-066-1818 LOZENGE in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/12/2016
Labeler - Meijer Distribution, Inc. (006959555)
Registrant - Bestco Inc. (002149136)
Establishment
NameAddressID/FEIOperations
Bestco Inc.002149136manufacture(41250-066)

 
Meijer Distribution, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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