Label: THROAT COAT EUCALYPTUS MINT- menthol lozenge

  • NDC Code(s): 78732-002-00, 78732-002-01, 78732-002-30
  • Packager: Traditional Medicinals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • Drug Facts

  • Active ingredient

    Active ingredient (per drop) Organic menthol 6 mg

  • Purpose

    Purposes cough suppressant / oral anesthetic

  • Uses

    Temporarily relieves

    • Cough due to minor throat and bronchial irritation occurring with the common cold and inhaled irritants.
    • Occasional minor irritaions, pain, sore mouth, and sore throat.
  • Warnings

    Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, or vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 12 years of age unless directed by physician.

  • Do not use

    Do not use:

    • If you are allergic to any of the ingredients.
    • Manufactured in a facility that also handles coconut oil
  • Ask a doctor before use

    Ask a doctor before use if you have:

    • A persistent or chronic cough such as occurs with smoking, asthma, or emphysema.
    • Cough accopanied by excessive phlegm (mucus)
  • Stop use and ask a doctor

    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 heacache. This could be the sign of a sereious condition.
    • Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting.
    • Sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persistst or worsesns.
  • Keep out of reach of children

    Keep out of reach of children.

  • Directions

    • Adults and children 12 years and over: Dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor, up to 5 lozenges per day
    • Children under 12 years of age: ask a doctor.
  • Other information

    • Each lozenge contains 10 mg of potassium.
    • Store in a cool, dry place.
    • Do not use if the outer wrap is opened or missing.
  • Inactive ingredients

    Organic eucalyptus oil, organic glulcose syrup, organic ivy extract, pectin, organic peppermint oil, organic rapeseed oil, organic raw cane sugar, water.

  • Questions

    call 1-800-543-4372, 9 a.m. - 5 p.m. PST M-F

  • SPL UNCLASSIFIED SECTION

    TRADITIONAL MEDICINALS ®

    ORGANIC Throat Coat ®

    Soothes Sore Throats & Relieves Coughs

    EUCALYPTUS MINT

    Cough Suppressant

    Oral Anesthetic

    16 MENTHOL COUGH DROPS

    Manufactured for:

    Traditional Medicinals

    1400 Valley House Dr, Suite 120

    Rohnert Park, CA 94928

    Product of Switzerland

  • PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    THROAT COAT  EUCALYPTUS MINT
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78732-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM6 mg  in 4.2 g
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    PECTIN (UNII: 89NA02M4RX)  
    WATER (UNII: 059QF0KO0R)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeOVALSize22mm
    FlavorMENTHOLImprint Code T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78732-002-0116 in 1 POUCH06/04/2020
    14.2 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:78732-002-3030 in 1 POUCH10/19/2023
    24.2 g in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:78732-002-002 in 1 POUCH10/27/2023
    34.2 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/04/2020
    Labeler - Traditional Medicinals, Inc. (107344810)
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