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mixed berry sore throat and cough lozenge

Medically reviewed on Dec 27, 2016

Dosage form: lozenge
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg, BENZOCAINE 7.5mg
Labeler: Super Valu
NDC Code: 41163-021

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 7.5 mg
Dextromethorphan hydrobromide 5 mg

Active ingredients (in each lozenge)

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 the common cold

Warnings

Sore throat warnings: 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 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, as 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 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 fever, 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.

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 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 one 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 take

Inactive ingredients: Acesulfame potassium, corn starch, corn syrup, glycerin, FD&C blue no. 1, FD&C red no. 40, natural and artificial flavors, medium chain triglycerides, propylene glycol, soybean oil, sucrose and water.

Questions? Or to report an adverse event call 1-877-932-7948

MIXED BERRY SORE THROAT AND COUGH LOZENGE 
benzocaine lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-021
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg
BENZOCAINE (BENZOCAINE) BENZOCAINE7.5 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
Product Characteristics
ColorredScoreno score
ShapeROUNDSize17mm
FlavorBERRYImprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-021-1818 LOZENGE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/16/2015
Labeler - Super Valu (006961411)
Registrant - Bestco Inc. (002149136)
Establishment
NameAddressID/FEIOperations
Bestco Inc.002149136manufacture(41163-021)

 
Super Valu

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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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