Label: HERBON WILD CHERRY- menthol and echinacea 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 October 15, 2009

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (per drop)

    Menthol 2mg

  • Purpose

    Soothes Sore Throats

  • Uses

    For the temporary relief of:

    • Occasional minor sore throat pain, irritation and sore mouth
  • Warnings

    Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, rash, swelling, or vomiting may be serious. Consult a physician promptly. Do not use more than 2 days. Do not administer to children under 3 years of age unless directed by a physician.

    Ask a doctor before use if you have:

    • Persistent or chronic cough associated with smoking, asthma, or emphysema
    • Cough accompanied by excessive phlegm (mucus)

    Stop use and ask a doctor if:

    • Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, persistent headache, rash, nausea, or vomiting.
    • Sore mouth symptoms do not improve in 2 days

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children - beware of accidental ingestion.

  • Directions

    • Adults and children 3 years of age and older: allow lozenge to dissolve slowly in the mouth. May be repeated every 2 hours as needed or as directed by a physician. Children under 3 years of age: consult a physician.
  • Inactive Ingredients:

    Citric Acid, Corn Syrup, Echinacea Angustifolia, Echinacea Purpurea, Elderberry, Elderberry Juice Color, Fritillaria, Licorice Root, Linden Flower, Natural Flavor, Sugar, Wild Cherry Bark.

  • Questions?

    800-421-2998

  • PRINCIPAL DISPLAY PANEL - 18 Lozenge Bag

    herbon®

    naturally flavored

    wild cherry
    herbal throat drops

    Soothing & Delicious

    Menthol - Soothes Sore Throats
    18 Drops      Net Wt 2.1oz (62g)

    Principal Display Panel - 18 Lozenge Bag
  • INGREDIENTS AND APPEARANCE
    HERBON WILD CHERRY 
    menthol and echinacea lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44597-5358
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol2 mg
    Echinacea (UNII: 4N9P6CC1DX) (Echinacea - UNII:4N9P6CC1DX) Echinacea100 mg
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP) 2 mg
    Fritillaria (UNII: 8B269H8XVH)  
    Sucrose (UNII: C151H8M554)  
    Corn Syrup (UNII: 9G5L16BK6N)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize23mm
    FlavorCHERRY (Wild Cherry) Imprint Code e
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44597-5358-012 in 1 CARTON
    118 in 1 CELLO PACK
    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
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