CEPACOL SORE THROAT MAXIMUM NUMBING CHERRY- benzocaine and menthol lozenge
CEPACOL SORE THROAT MAXIMUM NUMBING SUGAR FREE CHERRY- benzocaine and menthol lozenge
CEPACOL SORE THROAT MAXIMUM NUMBING CITRUS- benzocaine and menthol lozenge
CEPACOL SORE THROAT MAXIMUM NUMBING HONEY LEMON- benzocaine and menthol lozenge
Combe Incorporated

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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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.

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.

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.

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 - 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 - 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 - 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 - 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

Principal Display Panel - Honey Lemon - 18 Lozenges

CEPACOL SORE THROAT MAXIMUM NUMBING CHERRY
benzocaine and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11509-0011
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.6 mg

Ingredient Name	Strength
Inactive Ingredients
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	18mm
Flavor	CHERRY	Imprint Code	C
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11509-0011-1	2 in 1 CARTON	07/28/2003	10/08/2013
1		9 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	07/28/2003	10/08/2013

CEPACOL SORE THROAT MAXIMUM NUMBING SUGAR FREE CHERRY
benzocaine and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11509-0014
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 mg

Ingredient Name	Strength
Inactive Ingredients
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
MALTITOL (UNII: D65DG142WK)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	18mm
Flavor	CHERRY	Imprint Code	C
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11509-0014-1	1 in 1 CARTON	07/28/2003	10/08/2013
1		9 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	07/28/2003	10/08/2013

CEPACOL SORE THROAT MAXIMUM NUMBING SUGAR FREE CHERRY
benzocaine and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11509-0031
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 mg

Ingredient Name	Strength
Inactive Ingredients
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
MALTITOL (UNII: D65DG142WK)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	18mm
Flavor	CHERRY	Imprint Code	C
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11509-0031-1	2 in 1 CARTON	07/28/2003	10/08/2013
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	07/28/2003	10/08/2013

CEPACOL SORE THROAT MAXIMUM NUMBING CITRUS
benzocaine and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11509-0013
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.1 mg

Ingredient Name	Strength
Inactive Ingredients
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	18mm
Flavor	ORANGE	Imprint Code	C
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11509-0013-1	2 in 1 CARTON	07/28/2003	10/08/2013
1		9 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	07/28/2003	10/08/2013

CEPACOL SORE THROAT MAXIMUM NUMBING HONEY LEMON
benzocaine and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11509-0012
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.6 mg

Ingredient Name	Strength
Inactive Ingredients
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	18mm
Flavor	HONEY (Honey-Lemon)	Imprint Code	C
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11509-0012-1	2 in 1 CARTON	07/28/2003	10/08/2013
1		9 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	07/28/2003	10/08/2013

Labeler - Combe Incorporated (002406502)

Name	Address	ID/FEI	Business Operations
Establishment
First Boston Pharma LLC		618613590	MANUFACTURE(11509-0011, 11509-0014, 11509-0031, 11509-0013, 11509-0012)

Revised: 2/2017

Document Id: 9f705a1c-3f0b-4475-892a-71eb7be9640f

Set id: bbbb6557-975a-44c5-882a-1aba48e7b055

Version: 3

Effective Time: 20170227

Combe Incorporated