Label: HALLS HONEY- menthol lozenge

  • NDC Code(s): 12546-241-30, 12546-241-40, 12546-241-80
  • Packager: Mondelez Global LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 21, 2024

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  • Active Ingredient

    <(per drop) Menthol 1.8 mg>

  • Purposes

    <Cough suppressant, Oral anesthetic>

  • Uses

    <Temporarily relieves:

    • cough due to a cold
    • occasional minor irritation or sore throat>
  • 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.>

  • Ask a doctor before use if you have

    • <persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by excessive phlegm (mucus)>
  • 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 headache. These could be signs of a serious condition.
    • 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 3 drops (one at a time) 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

    <FD&C blue 1, FD&C red 40, FD&C yellow 5 (tartrazine), flavors, glucose syrup, honey, soy lecithin, sucrose, water>

  • Questions?

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

  • OTC Principal Display Panel

    Halls Honey 30 Drop Bag 12546-241-30

  • INGREDIENTS AND APPEARANCE
    HALLS  HONEY
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-241
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    HONEY (UNII: Y9H1V576FH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Coloryellow (Pale Yellow) Scoreno score
    ShapeOVALSize21mm
    FlavorHONEYImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-241-3030 in 1 BAG; Type 0: Not a Combination Product01/25/201906/21/2024
    2NDC:12546-241-4040 in 1 BAG; Type 0: Not a Combination Product01/25/201908/21/2023
    3NDC:12546-241-8080 in 1 BAG; Type 0: Not a Combination Product01/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/25/2019
    Labeler - Mondelez Global LLC (091849786)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc.246791201manufacture(12546-241)
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