Label: HERBON GLACIAL MINT- echinacea purpurea, menthol, and eucalyptus oil lozenge

  • 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 September 9, 2009

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

  • INDICATIONS AND USAGE

    Recommended Use: For the temporary relief of cough and sore throat pain. Helps relieve nasal congestion and make nasal passages feel clearer. Helps shorten the duration and relieve symptoms of the common cold.

  • Recommended Dose:

    Adolescents (10 to 14 years): Dissolve 1 lozenge slowly in the mouth three times daily or more as needed.

    Adults and adolescents (14 years and older): Dissolve 1 lozenge slowly in the mouth six times daily or more as needed.

    Note: Do not exceed 14 lozenges per day. Consult a health care practitioner for use beyond eight weeks.

  • Medicinal Ingredients:

    Each lozenge contains:

    Echinacea (Echinacea purpurea) root extract 22:1
      (equivalent to 162 mg dried herb) ................................7.35 mg

    Menthol (from Mentha arvensis leaf) ...................................10 mg

    Eucalyptus oil (Eucalyptus globulus) .....................................6 mg

  • INACTIVE INGREDIENT

    Non-medicinal Ingredients: Natural flavours (lemon, wintermint), natural colours (alfalfa, carmine, curcumin), corn syrup, sugar.

  • WARNINGS

    Risk Information: Consult a health care practitioner if symptoms persist or worsen, if sore throat symptoms are severe or persist for more than two days, if cough worsens, persists for more than seven days or is accompanied by high fever. Consult a health care practitioner prior to use if you take immunosuppressants or have a progressive systemic disease such as tuberculosis, leukosis, collagenosis or multiple sclerosis.

  • DO NOT USE

    DO NOT USE IF BAG IS OPEN OR TORN.

  • STORAGE AND HANDLING

    STORE IN A COOL, DRY PLACE.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL - 20 Lozenge Bag

    Herbon®

    ECHINACEA Cough and Sore Throat Drops

    Original

    Temporary Relief of
    Cough & Sore Throat
    Helps Ease Nasal Congestion

    ALL NATURALLY-SOURCED
    ACTIVE INGREDIENTS

    Extra Strength

    GLACIAL MINT

    REFRESHING
    BURTS
    of LEMON and
    WINTERMINT

    20 Lozenges

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    HERBON GLACIAL MINT 
    echinacea purpurea, menthol, and eucalyptus oil lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44597-5505
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Echinacea Purpurea (UNII: QI7G114Y98) (Echinacea - UNII:4N9P6CC1DX) Echinacea7.35 mg
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol10 mg
    Eucalyptus Oil (UNII: 2R04ONI662) (Eucalyptus Oil - UNII:2R04ONI662) Eucalyptus Oil6 mg
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554) 2150.04 mg
    Corn Syrup (UNII: 9G5L16BK6N)  
    Product Characteristics
    ColorYELLOW (Slightly opaque light yellowish green with deep pink and bright yellow speckles) Scoreno score
    ShapeROUNDSize20mm
    FlavorLEMON (lemon, wintermint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44597-5505-112 in 1 CARTON
    120 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/30/2009
    Labeler - Purity Life Division of SunOpta (243105843)
    Establishment
    NameAddressID/FEIBusiness Operations
    Purity Life Division of SunOpta243105843RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    F&F Laboratories Inc.005092838MANUFACTURE