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

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HALLS CHERRY (MENTHOL) LOZENGE [MONDEL?Z GLOBAL LLC]
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NDC 12546-165-09
Set ID 264c9542-3348-42e0-ae1b-62d4f27b300c
Category HUMAN OTC DRUG LABEL
Packager Mondelēz Global LLC
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active Ingredient

    (in each drop) Menthol 7 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 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 2, FDC red 40, flavors, glucose syrup, soy lecithin, sucralose, 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

    Enter section text hereNDC 12546-165-09 Halls Cherry 9 drops packageOTC Principal Display Panel 9 stick

  • INGREDIENTS AND APPEARANCE
    HALLS  CHERRY
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-165
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol7 mg
    Inactive Ingredients
    Ingredient NameStrength
    Eucalyptus oil (UNII: 2R04ONI662)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (red) Scoreno score
    ShapeSQUARESize21mm
    FlavorCHERRY (Cherry) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-165-0909 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2013
    Labeler - Mondelēz Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelēz Canada Inc.246791201manufacture(12546-165)
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