Your browser does not support JavaScript! CEPACOL SORE THROAT FROM POST NASAL DRIP (MENTHOL) LOZENGE [COMBE INCORPORATED]
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CEPACOL SORE THROAT FROM POST NASAL DRIP (menthol) lozenge
[Combe Incorporated]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

     

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11509-0003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL4.5 mg
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE 
ANHYDROUS DEXTROSE 
ACESULFAME POTASSIUM 
PROPYLENE GLYCOL 
D&C RED NO. 33 
SUCROSE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize18mm
FlavorCHERRYImprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11509-0003-12 in 1 CARTON
19 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)

Revised: 12/2009
 
Combe Incorporated

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