Label: SUGAR FREE MOUNTAIN HERB COUGH SUPPRESSANT THROAT DROPS- menthol lozenge

  • NDC Code(s): 63667-958-19, 63667-958-24, 63667-958-45
  • Packager: Ricola USA Inc.
  • 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 February 16, 2023

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.  Repeat every 2 hours as needed or as directed by a doctor
    • children under 6 years: ask a doctor
  • Other Information

    • Phenylketonurics: contains phenylalanine 1 mg per drop
    • excessive use may have a laxative effect
    • store in a dry place
    • 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 Diabetics

    © 2008 American Diabetes Association, American Dietetic Association

  • Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL

    Image of SF Original Swiss Herb 19 ct.jpg

  • INGREDIENTS AND APPEARANCE
    SUGAR FREE MOUNTAIN HERB COUGH SUPPRESSANT THROAT DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63667-958
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    ISOMALT (UNII: S870P55O2W)  
    SORBITOL (UNII: 506T60A25R)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CARAMEL (UNII: T9D99G2B1R)  
    Product Characteristics
    Colorbrown (DEER BROWN) Scoreno score
    ShapeOVALSize24mm
    FlavorMENTHOLImprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63667-958-1919 in 1 BAG; Type 0: Not a Combination Product04/12/1942
    2NDC:63667-958-2424 in 1 BAG; Type 0: Not a Combination Product04/12/194212/29/2017
    3NDC:63667-958-4545 in 1 BAG; Type 0: Not a Combination Product04/12/194212/29/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/12/1942
    Labeler - Ricola USA Inc. (177265261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ricola Ag485393768manufacture(63667-958)