Cepacol Sore Throat Plus Cough

Dosage form: lozenge
Ingredients: BENZOCAINE 7.5mg, DEXTROMETHORPHAN HYDROBROMIDE 5mg
Labeler: Combe Incorporated
NDC Code: 11509-0020

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 and Cough

Cēpacol® Sore Throat + Cough Lozenges

Active Ingredients (in each lozenge)

Benzocaine 7.5 mg                              

Purpose

Oral anesthetic

Active Ingredients (in each lozenge)

Dextromethorphan hydrobromide 5.0 mg            

Purpose

Cough suppressant

Uses

temporarily

  • relieves occasional minor irritation, pain, sore mouth and sore throat
  • controls cough due to minor throat and bronchial irritation associated with a cold

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 or give to children under 6 years of age.

Do not use this product if

you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAIO, ask a doctor or pharmacist before taking the product.

Ask a doctor before use if you have
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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.
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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 12 years of age and older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 12 lozenges in any 24 hour period, or as directed by a doctor.
  • 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, glucose, potassium acesulfame, propylene glycol, red 40, sodium bicarbonate, sucrose

Principal Display Panel

Maximum Numbing

Cēpacol®

Sore Throat

+ Cough Relief

Oral Analgesic/ Cough Suppressant Lozenges

Numbs

Relieves Cough

Suppresses Cough

Mixed Berry

18 Lozenges

CEPACOL SORE THROAT PLUS COUGH 
benzocaine and dextromethorphan hydrobromide lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-0020
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE7.5 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg
Inactive Ingredients
Ingredient NameStrength
D&C BLUE NO. 1 
CETYLPYRIDINIUM CHLORIDE 
ANHYDROUS DEXTROSE 
ACESULFAME POTASSIUM 
PROPYLENE GLYCOL 
D&C RED NO. 40 
SODIUM BICARBONATE 
SUCROSE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize18mm
FlavorBERRYImprint CodeC
Contains    
Packaging
#Item CodePackage Description
1NDC:11509-0020-12 BLISTER PACK (2 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 FINALpart34107/28/2005
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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