HALLS HONEY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]

HALLS HONEY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]
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NDC 12546-317-02, 12546-317-30, 12546-317-40, 12546-317-80
Set ID ddced999-782d-412f-a595-de751f2816f2
Category HUMAN OTC DRUG LABEL
Packager Mondelez Global LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • Active Ingredient

    <(in each drop) Menthol 2.7 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

  • Directions

    • < adults and children 5 years and over: dissolve 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed.
    • children under 5 years: ask a doctor>
  • Other information

    • <10 calories
    • contains: soy>
  • Inactive ingredients

    <FDC Blue 1, FDC Red 40, FDC Yellow 5 (tartrazine), flavors, glucose syrup, honey, 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 12546-317-30 Halls Honey 30 ct Bag>MM1

  • INGREDIENTS AND APPEARANCE
    HALLS  HONEY
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-317
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.7 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    HONEY (UNII: Y9H1V576FH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Coloryellow (yellow) Scoreno score
    ShapeOVALSize21mm
    FlavorHONEYImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-317-3030 in 1 BAG; Type 0: Not a Combination Product05/01/2015
    2NDC:12546-317-4040 in 1 BAG; Type 0: Not a Combination Product05/01/2015
    3NDC:12546-317-8080 in 1 BAG; Type 0: Not a Combination Product05/01/2015
    4NDC:12546-317-0202 in 1 BAG; Type 0: Not a Combination Product05/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2015
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc246791201manufacture(12546-317)

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