Label: HALLS SUGAR FREE HONEY LEMON- menthol lozenge

  • NDC Code(s): 12546-642-02, 12546-642-25, 12546-642-30, 12546-642-70, view more
    12546-642-79
  • 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 7.6 mg>

  • Purposes

    <Cough Suppressant, Oral Anesthetic>

  • Uses

    <temporarily relieves:

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

    <Sore throat warnings:  if sore throat is severe, persist 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

    • excessive consumption may have a laxative effect
    • 5 calories per drop
    • Contains:  SOY
  • Inactive ingredients

    <beta carotene, eucalyptus oil, flavors, isomalt, soy lecithin, sucralose, 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 sugar free honey lemon 25ct

  • INGREDIENTS AND APPEARANCE
    HALLS  SUGAR FREE HONEY LEMON
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-642
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ISOMALT (UNII: S870P55O2W)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Coloryellow (light yellow) Scoreno score
    ShapeOVALSize21mm
    FlavorLEMON (HONEY LEMON) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-642-2525 in 1 BAG; Type 0: Not a Combination Product05/27/201906/21/2024
    2NDC:12546-642-3030 in 1 BAG; Type 0: Not a Combination Product05/27/201905/21/2023
    3NDC:12546-642-79180 in 1 BAG; Type 0: Not a Combination Product05/27/2019
    4NDC:12546-642-7070 in 1 BAG; Type 0: Not a Combination Product05/27/2019
    5NDC:12546-642-022 in 1 BAG; Type 0: Not a Combination Product05/27/201905/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/27/2019
    Labeler - Mondelez Global LLC (091849786)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc.246791201manufacture(12546-642)
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