DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]

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DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]
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NDC 63667-242-19, 63667-242-26
Set ID 09141018-37ba-4c93-9051-1ed129c448c1
Category HUMAN OTC DRUG LABEL
Packager Ricola USA Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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  • Drug Facts

    Purpose

    Cough suppressant, Oral pain reliever

  • Active Ingredient (in each drop)

    Menthol, 8.5 mg

  • Uses

    temporarily relieves:

    • cough due to a cold or inhaled irritants
    • occasional minor irritation and pain due to sore throat or sore mouth
  • Warnings

    Sore throat warnings:

    • if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These may be serious,
    • do not use in children under 6 years of age unless directed by a doctor.
  • Ask doctor before use if you have

    • persistent chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by excessive phlegm (mucus)
  • Stop use and ask a doctor if

    • 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.
    • sore mouth does not improve in 7 days
    • irritation, pain, or redness persists or worsens
  • Keep out of reach of children.


  • Directions

    • adults and children 6 years and older:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
    • children under 6 years: ask a doctor
  • Other Information

    Store in a dry place

  • Inactive Ingredients

    extract of Ricola's herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), glycerin, malic acid, natural cherry concentrate, natural color, natural flavors, starch syrup, sugar
  • PRINCIPAL DISPLAY PANEL

    Image of DualActCherry19ct.jpg

  • INGREDIENTS AND APPEARANCE
    DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC  
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63667-242
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALIC ACID (UNII: 817L1N4CKP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize24mm
    FlavorCHERRYImprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63667-242-1919 in 1 BAG; Type 0: Not a Combination Product04/03/2011
    2NDC:63667-242-2626 in 1 BAG; Type 0: Not a Combination Product04/03/2011
    3NDC:63667-242-75175 in 1 BAG; Type 0: Not a Combination Product04/03/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/03/2011
    Labeler - Ricola USA Inc. (177265261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ricola Ag 485393768manufacture(63667-242)
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