HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]

HALLS HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]
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NDC 12546-319-25
Set ID 04c43a95-9e0e-42c9-8033-3323c2cfc5c3
Category HUMAN OTC DRUG LABEL
Packager Mondelez Global LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • 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 persist 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

    • 15 calories per drop
    • Contains: SOY.
  • Inactive ingredients

    <beta carotene, citric acid, eucalyptus oil, flavors, glucose syrup, glycerin, high fructose corn syrup, honey, lactic acid, potassium citrate, 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

    <NDC 12546-319-25 Halls Honey Lemon 25ct Bag>

    MM1

  • INGREDIENTS AND APPEARANCE
    HALLS  HONEY LEMON
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-319
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol7.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    HONEY (UNII: Y9H1V576FH)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize22mm
    FlavorHONEY (Honey Lemon) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-319-2525 in 1 BAG; Type 0: Not a Combination Product10/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/20/2019
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc.246791201manufacture(12546-319)

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