Label: EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT- menthol lozenge

  • NDC Code(s): 54305-617-04, 54305-617-19, 54305-617-26
  • Packager: Ricola Ag
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 January 18, 2023

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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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