MIXED BERRY SORE THROAT AND COUGH LOZENGE- benzocaine lozenge 
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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 lozenge)

Benzocaine 7.5 mg

Dextromethorphan hydrobromide 5 mg

Purpose

Oral pain reliever

Cough suppressant

Uses temporarily relieves these symptoms:

occasional minor mouth irritatin, sore mouth and sore throat

cough due to minor throat and bronchial irritation as may occur with the common cold

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 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:

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 fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant of 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 lozenge 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 - take 1 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 - 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 and adverse event call 1-800-245-2898. Monday - Friday, 9am to 4pm EST

CareOne Mixed Berry Benz-Dex 18ct Lozenges

MIXED BERRY SORE THROAT AND COUGH LOZENGE 
benzocaine lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-029
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
ColorredScoreno score
ShapeROUNDSize17mm
FlavorBERRYImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-029-1818 in 1 BLISTER PACK; Type 0: Not a Combination Product06/09/2016
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/09/201609/01/2018
Labeler - Ahold (809183973)
Registrant - Bestco Inc. (002149136)
Establishment
NameAddressID/FEIBusiness Operations
Bestco Inc.002149136manufacture(41520-029)

Revised: 10/2018
 
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