CVS PHARMACY COUGH RELIEF HONEY LEMON FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL) LOZENGE [CVS PHARMACY, INC.]

CVS PHARMACY COUGH RELIEF HONEY LEMON FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL) LOZENGE [CVS PHARMACY, INC.]
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NDC 59779-064-16
Set ID e0ac4eb0-5bf9-42e0-a641-50ec8d6bd33c
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
  • CVS Pharmacy Cough Relief Honey Lemon Flavor


  • ACTIVE INGREDIENT

    Active ingredients (in each lozenge)Purpose
    Dextromethorphan HBr 5 mgCough suppressant
    Menthol 5 mgOral pain reliever
  • Uses

    temporarily relieves these symptoms:

    • sore throat
    • sore mouth
    • minor mouth irritation
    • cough due to minor throat and bronchial irritation as may occur with the common cold
  • Warnings

    Sore throat warning

    • If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly.

    Do not use in a child under 6 years of age.

    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, or emphysema
    • cough that is accompanied by excessive phlegm (mucus)

    Stop use and ask a doctor or dentist if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain or redness persists or worsens
    • swelling develops
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness

    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 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 6 to under 12 years of age: take 1 lozenge 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 under 6 years of age, do not use
  • Other information

    • tamper evident: product is sealed in blister package for your protection. Do not use if carton is damaged or if printed seal on blister is broken or missing.
    • store at room temperature
  • Inactive ingredients

    Corn syrup, FD C yellow 10, FD C yellow 6, glycerin, natural and artificial flavors, propylene glycol, sucralose and water. Soybean oil and corn starch use as processing aids.

  • Questions?

    Or to report an adverse event call 1-800-245-2898. Monday-Friday 8AM to 4PM EST

  • CVS Pharmacy Cough Relief Honey Lemon Flavor, 16 Count (59779-064-16)

    Label

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY COUGH RELIEF HONEY LEMON FLAVOR 
    dextromethorphan hydrobromide, menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-064
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize18mm
    FlavorHONEY, LEMONImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-064-1616 in 1 CARTON; Type 0: Not a Combination Product05/19/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/19/2014
    Labeler - CVS Pharmacy, Inc. (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco, Inc.002149136manufacture(59779-064)

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