MIXED BERRY THROAT LOZENGE- benzocaine, dextromethorhan hydrobromide lozenge 
Topco

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 ingredient (in each lozenge)

Benzocaine 7.5 mg

Dextromethorphan hydrobromide 5.0 mg

Purpose

Oral Pain Reliever

Cough Suppressant

Uses temporailly relieves these symptoms:

  • occasional minor mouth irritation, sore mouth and sore throat
  • cough due to minor and bronchial irritation as may occur with the common cold

Warnings

Methemoglobinemia warning:

Use of this product may cause methemoglobinemia, a serious conditin 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 lasts or wordens, 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 any other “caine” anesthetics.

Do not use if you are 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 a MAOI, ask a doctor or pharmacist before taking this product.

  • for teething
  • 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 is accompanied by excessive 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 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.

Other Information

  • 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 1-888-423-0139

TopCare Mixed Berry Benz-Dex 18ct Lozenges

MIXED BERRY THROAT LOZENGE 
benzocaine, dextromethorhan hydrobromide lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-999
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
ColorredScorescore with uneven pieces
ShapeROUNDSize18mm
FlavorBERRYImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-999-1818 in 1 CARTON; Type 0: Not a Combination Product08/03/2015
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/03/201511/01/2018
Labeler - Topco (006935977)
Registrant - Bestco Inc. (002149136)
Establishment
NameAddressID/FEIBusiness Operations
Bestco Inc.002149136manufacture(36800-999)

Revised: 11/2018
 
Topco