EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA AG]

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EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT (MENTHOL) LOZENGE [RICOLA AG]
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NDC 54305-617-04, 54305-617-19, 54305-617-26
Set ID ea42e516-2ef8-41c9-ae4e-571f0147bc6b
Category HUMAN OTC DRUG LABEL
Packager Ricola Ag
Generic Name
Product Class
Product Number
Application Number PART341
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  • Drug Facts

    Purpose

    Cough suppressant

  • Active Ingredient (in each drop)

    Menthol, 8.3 mg

  • Uses

    temporarily relieves:

    • cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
  • Warnings

  • 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
  • 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

    extracts of peppermint and a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), glycerin, invert sugar (fructose/dextrose), natural flavor, starch syrup, sugar

  • PRINCIPAL DISPLAY PANEL

    Image of ExtraStrGlacierMint19ct.jpg

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54305-617
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8.3 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    INVERT SUGAR (UNII: ED959S6ACY)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize24mm
    FlavorMINTImprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54305-617-1919 in 1 BAG; Type 0: Not a Combination Product05/27/2013
    2NDC:54305-617-2626 in 1 BAG; Type 0: Not a Combination Product05/27/2013
    3NDC:54305-617-044 in 1 PACKAGE; Type 0: Not a Combination Product05/27/201301/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/27/2013
    Labeler - Ricola Ag (480227248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ricola Ag 485393768manufacture(54305-617)
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