Label: HALLS EXTRA STRONG MENTHOL MENTHOL- menthol lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 3, 2021

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  • Active Ingredients

    <(per drop) Menthol 20 mg>

  • Purposes

    <Oral anesthetic>

  • Uses

    <temporarily relieves occasional minor irritation and pain associated with:>

    -sore throat

    -sore mouth

  • Warnings

    <Sore throat warning: 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.>

  • Stop use and ask a doctor if

    • 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 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.
    • children under 5 years: ask a doctor
  • Other Information

    • 10 calories per drop
    • Contains: SOY.
  • Inactive Ingredients

    <citric acid, eucalyptus oil, FD&C blue 1, flavors, glucose syrup, potassium citrate, soy lecithin, sucralose, sucrose, water>

  • Questions

    <Call 1-800-524-2854, Monday to Friday, 9AM-6PM Eastern Time or visit our website at www.gethalls.com>

  • OTC Principal Display Panel

    <NDC12546-341-30 Halls Extra Strong Menthol Flavor 30ct Bag> image description

  • INGREDIENTS AND APPEARANCE
    HALLS  EXTRA STRONG MENTHOL MENTHOL
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-341
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (White with blue specks) Scoreno score
    ShapeOVALSize21mm
    FlavorMENTHOL (Extra Strong Menthol) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-341-3030 in 1 BAG; Type 0: Not a Combination Product07/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/26/2019
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc.246791201manufacture(12546-341)
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