HALLS BUTTERSCOTCH (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]

HALLS BUTTERSCOTCH (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]
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NDC 12546-108-20
Set ID 9a2a7771-1fc0-4999-977b-fa1c02f8ce34
Category HUMAN OTC DRUG LABEL
Packager Mondelez Global LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • Active Ingredient

    <(in each drop) Menthol 5 mg>

  • Purposes

    <Cough Suppressant, Oral Anesthetic>

  • Uses

    • 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, caramel color, flavors, glucose syrup, glycerin, partially hydrogenated cottonseed oil, 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

    OTC PDPEnter section text here<USNDC 12546-108-20 and CA NDC 67238-108-20 Halls Warm Ups Butterscotch 20 drops bag>

  • INGREDIENTS AND APPEARANCE
    HALLS  BUTTERSCOTCH
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-108
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol5 mg
    Inactive Ingredients
    Ingredient NameStrength
    BETA CAROTENE (UNII: 01YAE03M7J)  
    CARAMEL (UNII: T9D99G2B1R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorbrown (LIGHT BROWN) Scoreno score
    ShapeOVALSize22mm
    FlavorBUTTERSCOTCH (BUTTERSCOTCH FLAVOR) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-108-2020 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/01/2011
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc246791201manufacture(12546-108)

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