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
  • 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 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 Product03/24/2019
    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 finalM01203/24/2019
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc.246791201manufacture(12546-110)
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