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Cepacol Sore Throat Maximum Numbing Cherry

Dosage form: lozenge
Ingredients: BENZOCAINE 15mg, MENTHOL 3.6mg
Labeler: Combe Incorporated
NDC Code: 11509-0011

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.

Cepacol Sore Throat Maximum Numbing

Cēpacol® Sore Throat Maximum Numbing Cherry Lozenges

Active Ingredients (in each lozenge)

Benzocaine 15.0 mg                              

Purpose

Oral anesthetic

Active Ingredients (in each lozenge)

Menthol 3.6 mg                              

Purpose

Oral analgesic

Uses

temporarily relieves occasional:

  • sore throat pain
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores

Warnings

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.

Sore Throat Warning:  Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious.  Consult a doctor promptly.  Do not use for more than 2 days or give to children under 5 years of age.

Stop use and ask a doctor if

sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens.

If pregnant or breast feeding

ask a health professional before use.

Keep this and all drugs out of reach of children

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

Do not exceed recommended dosage.

Directions
  • adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
  • children under 5 years of age: do not use.

Other information   
  • store at room temperature (68-77°F) (20-25°C)  
  • protect contents from humidity

Inactive ingredients  

cetylpyridinium chloride (Ceepryn®), flavor, glucose, potassium acesulfame, propylene glycol, red 33, red 40, sodium bicarbonate, sucrose





Cēpacol® Sore Throat Maximum Numbing Sugar Free Cherry Lozenges

Active Ingredients (in each lozenge)

Benzocaine 15.0 mg                              

Purpose

Oral anesthetic

Active Ingredients (in each lozenge)

Menthol 4.0 mg                              

Purpose

Oral analgesic

Uses

temporarily relieves occasional:

  • sore throat pain
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores

Warnings

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.

Sore Throat Warning:  Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious.  Consult a doctor promptly.  Do not use for more than 2 days or give to children under 5 years of age.

Stop use and ask a doctor if

sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens.

If pregnant or breast feeding

ask a health professional before use.

Keep this and all drugs out of reach of children

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

Do not exceed recommended dosage.

Directions
  • adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
  • children under 5 years of age: do not use.

Other information
  • store at room temperature (68-77°F) (20-25°C)   
  • protect contents from humidity

Inactive ingredients

cetylpyridinium chloride (Ceepryn®), flavor, isomalt, maltitol, potassium acesulfame, propylene glycol, red 33, red 40, sodium bicarbonate





Cēpacol® Sore Throat Maximum Numbing Citrus Lozenges

Active Ingredients (in each lozenge)

Benzocaine 15.0 mg                              

Purpose

Oral anesthetic

Active Ingredients (in each lozenge)

Menthol 2.1 mg                              

Purpose

Oral analgesic

Uses

temporarily relieves occasional:

  • sore throat pain
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores

Warnings

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.

Sore Throat Warning:  Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious.  Consult a doctor promptly.  Do not use for more than 2 days or give to children under 5 years of age.

Stop use and ask a doctor if

sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens.

If pregnant or breast feeding

ask a health professional before use.

Keep this and all drugs out of reach of children

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

Do not exceed recommended dosage.

Directions
  • adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
  • children under 5 years of age: do not use.

Other information
  • store at room temperature (68-77°F) (20-25°C)   
  • protect contents from humidity

Inactive ingredients

cetylpyridinium chloride (Ceepryn®), flavor, isomalt, maltitol syrup, propylene glycol, sodium bicarbonate, sucralose, yellow 6





Cēpacol® Sore Throat Maximum Numbing Honey Lemon Lozenges

Active Ingredients (in each lozenge)

Benzocaine 15.0 mg                              

Purpose

Oral anesthetic

Active Ingredients (in each lozenge)

Menthol 2.6 mg                              

Purpose

Oral analgesic

Uses

temporarily relieves occasional:

  • sore throat pain
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores

Warnings

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.

Sore Throat Warning:  Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious.  Consult a doctor promptly.  Do not use for more than 2 days or give to children under 5 years of age.

Stop use and ask a doctor if

sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens.

If pregnant or breast feeding

ask a health professional before use.

Keep this and all drugs out of reach of children

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

Do not exceed recommended dosage.

Directions
  • adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
  • children under 5 years of age: do not use.

Other information
  • store at room temperature (68-77°F) (20-25°C)   
  • protect contents from humidity

Inactive ingredients

cetylpyridinium chloride (Ceepryn®), flavor, isomalt, maltitol syrup, propylene glycol, sodium bicarbonate, sucralose, yellow 6, yellow 10.

Principal Display Panel

Maximum Numbing

Cēpacol®

Sore Throat

Oral Anesthetic/Analgesic Lozenges Pain Relief

Works Instantly

Relieves and Soothes

CHERRY

18 Lozenges

Principal Display Panel

Maximum Numbing

Cēpacol®

Sore Throat

Oral Anesthetic/Analgesic Lozenges Pain Relief

Works Instantly

Relieves and Soothes

CHERRY

9 Lozenges

Principal Display Panel

SUGAR FREE

Maximum Numbing

Cēpacol®

Sore Throat

Oral Anesthetic/Analgesic Lozenges Pain Relief

Works Instantly

Relieves and Soothes

CHERRY

16 Lozenges

Principal Display Panel

SUGAR FREE

Maximum Numbing

Cēpacol®

Sore Throat

Oral Anesthetic/Analgesic Lozenges Pain Relief

Works Instantly

Relieves and Soothes

CITRUS

18 Lozenges

Principal Display Panel

SUGAR FREE

Maximum Numbing

Cēpacol®

Sore Throat

Oral Anesthetic/Analgesic Lozenges Pain Relief

Works Instantly

Relieves and Soothes

CITRUS

18 Lozenges

CEPACOL SORE THROAT MAXIMUM NUMBING CHERRY 
benzocaine and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-0011
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE15 mg
MENTHOL (MENTHOL) MENTHOL3.6 mg
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE 
ANHYDROUS DEXTROSE 
ACESULFAME POTASSIUM 
PROPYLENE GLYCOL 
D&C RED NO. 33 
SODIUM BICARBONATE 
SUCROSE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize18mm
FlavorCHERRYImprint CodeC
Contains    
Packaging
#Item CodePackage Description
1NDC:11509-0011-12 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
19 LOZENGE (9 LOZENGE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35607/28/2003
CEPACOL SORE THROAT MAXIMUM NUMBING SUGAR FREE CHERRY 
benzocaine and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-0014
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE15 mg
MENTHOL (MENTHOL) MENTHOL4 mg
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE 
ACESULFAME POTASSIUM 
PROPYLENE GLYCOL 
D&C RED NO. 33 
SODIUM BICARBONATE 
MALTITOL 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize18mm
FlavorCHERRYImprint CodeC
Contains    
Packaging
#Item CodePackage Description
1NDC:11509-0014-11 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
19 LOZENGE (9 LOZENGE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35607/28/2003
CEPACOL SORE THROAT MAXIMUM NUMBING SUGAR FREE CHERRY 
benzocaine and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-0031
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE15 mg
MENTHOL (MENTHOL) MENTHOL4 mg
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE 
ACESULFAME POTASSIUM 
PROPYLENE GLYCOL 
D&C RED NO. 33 
SODIUM BICARBONATE 
MALTITOL 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize18mm
FlavorCHERRYImprint CodeC
Contains    
Packaging
#Item CodePackage Description
1NDC:11509-0031-12 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
18 LOZENGE (8 LOZENGE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35607/28/2003
CEPACOL SORE THROAT MAXIMUM NUMBING CITRUS 
benzocaine and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-0013
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE15 mg
MENTHOL (MENTHOL) MENTHOL2.1 mg
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE 
PROPYLENE GLYCOL 
SODIUM BICARBONATE 
SUCRALOSE 
D&C YELLOW NO. 6 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize18mm
FlavorORANGEImprint CodeC
Contains    
Packaging
#Item CodePackage Description
1NDC:11509-0013-12 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
19 LOZENGE (9 LOZENGE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35607/28/2003
CEPACOL SORE THROAT MAXIMUM NUMBING HONEY LEMON 
benzocaine and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-0012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE15 mg
MENTHOL (MENTHOL) MENTHOL2.6 mg
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE 
PROPYLENE GLYCOL 
SODIUM BICARBONATE 
SUCRALOSE 
D&C YELLOW NO. 6 
D&C YELLOW NO. 10 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize18mm
FlavorHONEY (Honey-Lemon) Imprint CodeC
Contains    
Packaging
#Item CodePackage Description
1NDC:11509-0012-12 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
19 LOZENGE (9 LOZENGE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35607/28/2003
Labeler - Combe Incorporated (002406502)
Establishment
NameAddressID/FEIOperations
First Boston Pharma LLC618613590MANUFACTURE

Revised: 12/2009
 
Combe Incorporated

Further information

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

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