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Cherry Sore Throat Lozenge by TopCo

Dosage form: lozenge
Ingredients: MENTHOL 3.6mg, BENZOCAINE 15mg
Labeler: TopCo
NDC Code: 36800-832

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 15 mg
Menthol 3.6 mg

Active ingredients (in each lozenge)

Benzocaine 15 mg

Menthol 3.6 mg

Purpose

Oral anesthetic

Oral anesthetic

Uses temporarily relieves these symptoms:

occasional minor irritation, pain, sore mouth and sore throat

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)
  • hearache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

Sore throat warning: If sore throat is severe, persistent 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 persist 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

  • for teething
  • in children under 2 years of age

Stop use and ask doctor if

sore throat is severe or irritation, pain, or redness persists or worsens

sore mouth symptoms do not improve in 7 days

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 5 years and older - allow 1 lozenge to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.

children under 5 years - do not use

Other information

store at room temperature

protect from moisture

Inactive ingredients: Corn starch, FD&C Red #40, glucose syrup, glycerin, medium chain triglycerides, natural & artificial flavors, propylene glycol, soybean oil, sucrose and water.

Questions? Or to report an adverse event call 1-888-423-0139.

CHERRY SORE THROAT LOZENGE 
benzocaine lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-832
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3.6 mg
BENZOCAINE (BENZOCAINE) BENZOCAINE15 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
Product Characteristics
ColorredScoreno score
ShapeROUNDSize17mm
FlavorCHERRYImprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-832-1818 LOZENGE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/19/2017
Labeler - TopCo (006935977)
Registrant - Bestco Inc. (002149136)
Establishment
NameAddressID/FEIOperations
Bestco Inc.002149136manufacture(36800-832)

 
TopCo

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Medically reviewed on Aug 2, 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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