HALLS ICE PEPPERMINT (MENTHOL) LOZENGE [MONDEL?Z GLOBAL LLC]

HALLS ICE PEPPERMINT (MENTHOL) LOZENGE [MONDEL?Z GLOBAL LLC]
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NDC 12546-101-09
Set ID 3e3e899d-6074-4c75-8ffa-0273fe7216b3
Category HUMAN OTC DRUG LABEL
Packager Mondelēz Global LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • Active ingredient

    <(per drop) Menthol 10 mg>

  • Purposes

    <Cough suppressant, Oral anesthetic>

  • INDICATIONS & USAGE

    <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

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

    <eucalyptus oil, FDC blue 1, flavors, glucose syrup, soy lecithin, sucrose, water>

  • Questions?

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

  • OTC Principal Display Panel

    <NDC 12546-101-09 Halls Ice Peppermint 9ct stick>

    MM1

  • INGREDIENTS AND APPEARANCE
    HALLS  ICE PEPPERMINT
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol10 mg
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorblue (aqua with blue glitter) Scoreno score
    ShapeSQUARE (square) Size21mm
    FlavorPEPPERMINT (Ice Peppermint) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-101-099 in 1 PACKAGE; Type 0: Not a Combination Product07/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/07/2019
    Labeler - Mondelēz Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelēz Canada Inc.246791201manufacture(12546-101)

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