Label: MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC- menthol lozenge

  • NDC Code(s): 63667-185-19, 63667-185-45
  • Packager: Ricola USA Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 10, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

    Purpose

    Cough suppressant, Oral anesthetic

  • Active Ingredient (in each drop)

    Menthol, 4.8 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 2 drops (one at a time) slowly in the mouth.  Do not bite or chew.  Repeat every 2 hours as needed or as directed by a doctor
    • children under 6 years: ask a doctor
  • Other Information

    • excessive use may have a laxative effect
    • protect from heat and moisture
    • product may be useful for diabetics on the advice of a doctor

    Exchange information:  2 Drops - FREE Exchange

    7 Drops = 1 Fruit

    Dietary exchanges based on Exchange Lists for Diabetes

    ©2008 American Diabetes Association, American Dietetic Association.

  • Inactive Ingredients

    color (caramel), extract of a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), isomalt, natural flavor, rebaudioside a, sorbitol

  • PRINCIPAL DISPLAY PANEL

    Image of SFMountainHerbwStevia19ct.jpg

  • INGREDIENTS AND APPEARANCE
    MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63667-185
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARAMEL (UNII: T9D99G2B1R)  
    ISOMALT (UNII: S870P55O2W)  
    SORBITOL (UNII: 506T60A25R)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    Product Characteristics
    Colorbrown (DEER BROWN) Scoreno score
    ShapeOVALSize24mm
    FlavorMENTHOL (MOUNTAIN HERB) Imprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63667-185-1919 in 1 PACKAGE; Type 0: Not a Combination Product09/01/2015
    2NDC:63667-185-4545 in 1 PACKAGE; Type 0: Not a Combination Product09/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/01/2015
    Labeler - Ricola USA Inc. (177265261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ricola Ag 485393768manufacture(63667-185)