CVS SORE THROAT MIXED BERRY FLAVOR (BENZOCAINE, DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [CVS PHARMACY, INC.]

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  • CVS SORE THROAT MIXED BERRY FLAVOR (BENZOCAINE, DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [CVS PHARMACY, INC.]

CVS SORE THROAT MIXED BERRY FLAVOR (BENZOCAINE, DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [CVS PHARMACY, INC.]
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NDC 59779-649-18
Set ID d77e4d65-9b50-4761-94e5-eae4a3c7c2c6
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy, Inc.
Generic Name
Product Class
Product Number
Application Number PART356
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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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