Cepacol Sore Throat Regular Strength

Dosage form: lozenge
Ingredients: MENTHOL 3mg
Labeler: Combe Incorporated
NDC Code: 11509-0001

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 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

CEPACOL SORE THROAT REGULAR STRENGTH 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-0001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3 mg
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE 
ANHYDROUS DEXTROSE 
PEPPERMINT OIL 
PROPYLENE GLYCOL 
SUCROSE 
D&C YELLOW NO. 10 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize18mm
FlavorMENTHOLImprint CodeC
Contains    
Packaging
#Item CodePackage Description
1NDC:11509-0001-172 BLISTER PACK (72 BLISTER PACK) in 1 CARTON
19 LOZENGE (9 LOZENGE) 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)
Establishment
NameAddressID/FEIOperations
First Boston Pharma LLC618613590MANUFACTURE

Revised: 12/2009
 
Combe Incorporated

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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