CVS SORE THROAT MIXED BERRY FLAVOR- benzocaine, dextromethorphan hydrobromide lozenge 
CVS Pharmacy, Inc.

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.

----------

CVS Mixed Berry Sore Throat

CVS Sore Throat Mixed Berry Flavor

Active ingredients (in each lozenge)Purpose
Benzocaine 7.5 mgOral Pain Reliever

Dextromethorphan hydrobromide 5 mg

Oral Pain Reliever

Uses

temporarily relieves these symptoms:

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, rash, nausea, and vomiting may be serious. Consult a dentist or doctor right away. Do not use more than 2 days or administer to children under 5 years of age unless directed by a doctor.

Do not use 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 MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

• cough that occurs with too much phlegm (mucus)

Stop Use and ask a doctor or dentist  if

  • sore mouth symptom do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling developes
  • cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Acesulfame potassium, corn syrup, FD&C Blue #1, FD&C Red #40, natural and artificial flavors (medium chain triglycerides), propylene glycol, sucrose, and water.  Soybean oil and corn starch used as processing aids.

Questions ?

Call 1-800-245-2898. Monday through Friday, 9AM - 4PM EST. 

CVS Sore Throat Lozenges Mixed Berry Flavor 18 Count (59779-649-18)

CVS pharmacy

compare to the active ingredients in Cepacol**

SORE THROAT &

COUGH LOZENGES

SOOTHING RELIEF

BENZOCAINE 7.5 mg/DEXTROMETHORPHAN HBr 5 mg

Temporarily relieves:

Mixed Berry Flavor

18 LOZENGES

DISTRIBUTED BY:

CVS Pharmacy, Inc.

One Cvs Drive Woonsocket, RI 02895

2014 CVS/Pharmacy

CVS.com    1-800-SHOP CVS

Made in the USA

This product is not manufactured or distributed

by Reckftt Bencldser owner af the registered

trademark Cepacol.

front

back

CVS SORE THROAT MIXED BERRY FLAVOR 
benzocaine, dextromethorphan hydrobromide lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-649
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CORN SYRUP (UNII: 9G5L16BK6N)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
SOYBEAN OIL (UNII: 241ATL177A)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorpurpleScoreno score
ShapeROUNDSize23mm
FlavorBERRYImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-649-1818 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/22/2014
Labeler - CVS Pharmacy, Inc. (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Bestco, Inc.002149136manufacture(59779-649)

Revised: 4/2014
Document Id: 770201f8-0e29-4771-bc3c-f9bb0438cba0
Set id: d77e4d65-9b50-4761-94e5-eae4a3c7c2c6
Version: 1
Effective Time: 20140422
 
CVS Pharmacy, Inc.