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Mixed Berry Sore Throat and Cough lozenge

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

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

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:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Sore throat warning: If sore throat is severe, persists for more than 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 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.

  • for teeting
  • in children under 2 years of age

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.

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

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, 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

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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Medically reviewed on Aug 9, 2018

Further information

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

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