CEPACOL SORE THROAT REGULAR STRENGTH- 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 Regular Strength

Cēpacol® Sore Throat Regular Strength Menthol Flavor Lozenges

(Note: This is sold only to institutions, only has foil backing with minimum text with the full drug facts box on the outside of the shipping carton)

Active Ingredients (in each lozenge)

Menthol 3 mg

Purpose

Oral analgesic

Uses

temporarily relieves occasional:

sore throat pain
sore mouth
minor mouth irritation

Warnings

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®), glucose, peppermint (mentha piperita) oil, propylene glycol, sucrose, yellow 10

Principal Display Panel

Cēpacol®

Sore Throat

REGULAR STRENGTH

MENTHOL FLAVOR

72 blister packages

contains 648 LOZENGES

Menthol Oral Analgesic Lozenges

Fast Soothing Relief of Minor Sore Throat Pain

Principal Display Panel

CEPACOL SORE THROAT REGULAR STRENGTH
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11509-0001
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 mg

Ingredient Name	Strength
Inactive Ingredients
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
PEPPERMINT OIL (UNII: AV092KU4JH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCROSE (UNII: C151H8M554)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11509-0001-1	72 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(11509-0001)

Revised: 2/2017

Document Id: a96ad1b8-5e00-4760-a866-dcb21fb881af

Set id: 599912f1-f888-4528-a676-78ef9a15b128

Version: 2

Effective Time: 20170227

Combe Incorporated