CEPACOL SORE THROAT FROM POST NASAL DRIP- 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.

----------

Cepacol Sore Throat from Post Nasal Drip

Cēpacol® Sore Throat from Post Nasal Drip Cherry Lozenges

Active Ingredients (in each lozenge)

Menthol 4.5 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®), flavor, glucose, propylene glycol, red 33, red 40, sucrose

Principal Display Panel

COOLING VAPOR RELIEF

Cēpacol®

Sore Throat

from Post Nasal Drip

Menthol Oral Analgesic Lozenges

Works Instantly

#1 in Hospitals*

CHERRY

18 Lozenges

Principal Display Panel

CEPACOL SORE THROAT FROM POST NASAL DRIP
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11509-0003
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.5 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)
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:11509-0003-1	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)

Revised: 2/2017

Document Id: b8c0c546-66d1-413c-a919-879a88b5bd7f

Set id: 2c5ca708-e836-4424-b28b-d9f104fe4c10

Version: 3

Effective Time: 20170227

Combe Incorporated