Label: CVS SORE THROAT MIXED BERRY FLAVOR- benzocaine, dextromethorphan hydrobromide lozenge

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated April 22, 2014

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  • CVS Sore Throat Mixed Berry Flavor

  • ACTIVE INGREDIENT

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

    Dextromethorphan hydrobromide 5 mg

    		Oral Pain Reliever
  • Uses

    temporarily relieves these symptoms:

    • occasional minor irritation, pain, sore mouth and sore throat
    • pain associated with canker sores
    • cough due to minor throat and bronchial irritation as may occur with common 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, 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

    • adults and children 12 years and older: take 2 lozenges (one immediately after the other) and allow to dissolve slowly in the mouth. May be repeated every 4 hours, not to exceed 6 lozenges in 24-hours, or as directed by a doctor

    • children 6 to under 12 years of age: take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours

    • children 6 years of age: do not use

  • Other information

    • store at room temperature
    • protect from moisture
  • 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:

    • Minor sore throat &mouth irritation
    • Cough due to minor throat irritation

    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

  • INGREDIENTS AND APPEARANCE
    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)
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