CEPACOL SORE THROAT PLUS COUGH- benzocaine and dextromethorphan hydrobromide 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 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

Principal Display Panel

CEPACOL SORE THROAT PLUS COUGH 
benzocaine and dextromethorphan hydrobromide lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-0020
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7.5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize18mm
FlavorBERRYImprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11509-0020-12 in 1 CARTON07/28/200510/08/2013
19 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34107/28/200510/08/2013
Labeler - Combe Incorporated (002406502)
Establishment
NameAddressID/FEIBusiness Operations
First Boston Pharma LLC618613590MANUFACTURE(11509-0020)

Revised: 2/2017
Document Id: 903b24cc-f784-409b-aa52-44852cf6e800
Set id: 6d2535db-1c54-42f4-9e76-f482433c3901
Version: 3
Effective Time: 20170227
 
Combe Incorporated