Label: HERBON SUGAR FREE LEMON HONEY- menthol and echinacea purpurea lozenge

  • Category: HUMAN OTC DRUG LABEL

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 October 15, 2009

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  • INDICATIONS AND USAGE

    Recommended Use: For the temporary relief of cough and sore throat pain. Soothes throat irritation. 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) .................................8 mg

  • INACTIVE INGREDIENT

    Non-medicinal Ingredients: Natural flavours (honey lemon, lemon), natural colours (beta carotene, curcumin), citric acid, isomalt, xylitol.

  • 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 - 18 Lozenge Bag

    Herbon®

    ECHINACEA Cough and Sore Throat Drops

    Sugar-Free

    Temporary Relief of
    Cough & Sore Throat
    Helps Ease Nasal Congestion

    ALL NATURALLY-SOURCED
    ACTIVE INGREDIENTS

    LEMON HONEY

    REFRESHING
    BURSTS
    of LEMON

    18 Lozenges

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    HERBON SUGAR FREE LEMON HONEY 
    menthol and echinacea purpurea lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44597-5535
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol8 mg
    Echinacea Purpurea (UNII: QI7G114Y98) (Echinacea - UNII:4N9P6CC1DX) Echinacea7.35 mg
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP) 16.93 mg
    Xylitol (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorYELLOW (Transulucent golden yellow with opaque yellow speckles) Scoreno score
    ShapeROUNDSize20mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44597-5535-012 in 1 CARTON
    118 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 Co. (243105843)
    Establishment
    NameAddressID/FEIBusiness Operations
    Purity Life Division of SunOpta Co.243105843RELABEL, REPACK
    Establishment
    NameAddressID/FEIBusiness Operations
    F&F Laboratories Inc.005092838MANUFACTURE