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
  • 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 July 20, 2023

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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 Product01/25/2019
    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 finalpart34101/25/2019
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc.246791201manufacture(12546-241)
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