CEPACOL SORE THROAT PLUS COATING- benzocaine and pectin 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 and Coating

Cēpacol® Sore Throat + Coating Lozenges

Active Ingredients (in each lozenge)

Benzocaine 15.0 mg

Purpose

Oral anesthetic

Active Ingredients (in each lozenge)

Pectin 5.0 mg

Purpose

Oral demulcent

Uses

temporarily

relieves occasional minor irritation, pain and discomfort of sore throat and sore mouth
protects irritated areas in sore throat and sore mouth

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 unless directed by a doctor.

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 6 years of age and 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 6 years of age: do not use.

Other information

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

Inactive ingredients

blue 1, cetylpyridinium chloride (Ceepryn®), flavor, isomalt, maltitol, potassium acesulfame, propylene glycol, sodium bicarbonate, yellow 10

Principal Display Panel

SUGAR FREE

Maximum Numbing

Cēpacol®

Sore Throat

+ Coating Relief

Oral Analgesic/Demulcent Lozenges

Numbs

Protects

Coats a Raw Throat

LEMON LIME

18 Lozenges

Principal Display Panel

CEPACOL SORE THROAT PLUS COATING
benzocaine and pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11509-0040
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	5 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
MALTITOL (UNII: D65DG142WK)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11509-0040-1	2 in 1 CARTON	08/31/2006	12/10/2013
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	08/31/2006	12/10/2013

Labeler - Combe Incorporated (002406502)

Name	Address	ID/FEI	Business Operations
Establishment
First Boston Pharma LLC		618613590	MANUFACTURE(11509-0040)

Revised: 2/2017

Document Id: d86f3cd1-98b3-4e83-96a8-f705d326663c

Set id: 634a8e8a-4a7b-4eed-ba34-b06acb9c6525

Version: 3

Effective Time: 20170227

Combe Incorporated