Label: HALLS HONEY LEMON- menthol lozenge

  • NDC Code(s): 12546-110-00, 12546-110-01, 12546-110-02, 12546-110-03, view more
    12546-110-04, 12546-110-14, 12546-110-16, 12546-110-18, 12546-110-24, 12546-110-30, 12546-110-40, 12546-110-80, 12546-110-96, 12546-110-99
  • Packager: Mondelez Global LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 21, 2024

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  • Active ingredient

    <(per drop) Menthol 7.5 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

    Enter section text here

  • 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

    <beta carotene, eucalyptus oil, flavors, glucose syrup, honey, soy lecithin, sucralose, sucrose, water>

  • Questions

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

  • OTC Principal Display Panel

    Halls Honey lemon 30ct

  • INGREDIENTS AND APPEARANCE
    HALLS  HONEY LEMON
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-110
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HONEY (UNII: Y9H1V576FH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    Product Characteristics
    Coloryellow (yellow) Scoreno score
    ShapeOVALSize21mm
    FlavorHONEY (HONEY LEMON) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-110-1818 in 1 BAG; Type 0: Not a Combination Product03/24/201909/16/2022
    2NDC:12546-110-3030 in 1 BAG; Type 0: Not a Combination Product03/24/2019
    3NDC:12546-110-2424 in 1 BAG; Type 0: Not a Combination Product12/02/201906/11/2023
    4NDC:12546-110-4040 in 1 BAG; Type 0: Not a Combination Product03/24/201907/22/2023
    5NDC:12546-110-8080 in 1 BAG; Type 0: Not a Combination Product03/24/2019
    6NDC:12546-110-1616 in 1 BAG; Type 0: Not a Combination Product03/24/201909/16/2022
    7NDC:12546-110-9696 in 1 BAG; Type 0: Not a Combination Product03/24/201904/21/2020
    8NDC:12546-110-1414 in 1 PACKAGE; Type 0: Not a Combination Product03/24/2019
    9NDC:12546-110-99160 in 1 BAG; Type 0: Not a Combination Product03/24/201906/21/2024
    10NDC:12546-110-02150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product12/02/201909/16/2022
    11NDC:12546-110-032400 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product12/02/201909/16/2022
    12NDC:12546-110-04720 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product12/02/201909/16/2022
    13NDC:12546-110-00250 in 1 JAR; Type 0: Not a Combination Product07/06/2022
    14NDC:12546-110-01140 in 1 BAG; Type 0: Not a Combination Product04/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/24/2019
    Labeler - Mondelez Global LLC (091849786)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc.246791201manufacture(12546-110)
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