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

HALLS MENTHOLYPTUS (MENTHOL) LOZENGE [MONDEL?Z GLOBAL LLC]
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NDC 12546-334-09
Set ID f5292c5b-5608-4e13-afc2-4f3d7133da88
Category HUMAN OTC DRUG LABEL
Packager Mondelēz Global LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • Active ingredient

    <(per drop) Menthol 6.4 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

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

    <citric acid, eucalyptus oil, FDC blue 1, FDC red 40, flavors, glucose syrup, potassium citrate, 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 12546-334-09 Halls Mentho-Lyptus Stick 9ct>

    MM1

  • INGREDIENTS AND APPEARANCE
    HALLS  MENTHOLYPTUS
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-334
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol6.4 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    eucalyptus oil (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    sucrose (UNII: C151H8M554)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (white with blue specks) Scoreno score
    ShapeSQUARESize21mm
    FlavorMENTHOL (Mentholyptus) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-334-0909 in 1 PACKAGE; Type 0: Not a Combination Product04/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/07/2019
    Labeler - Mondelēz Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelēz Canada Inc.246791201manufacture(12546-334)

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