HALLS EXTRA STRONG MENTHOL (MENTHOL) LOZENGE [MONDEL?Z GROUP LLC]

HALLS EXTRA STRONG MENTHOL (MENTHOL) LOZENGE [MONDEL?Z GROUP LLC]
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NDC 12546-311-02, 12546-311-30
Set ID ae5be781-e2a6-443b-ae98-11c403789278
Category HUMAN OTC DRUG LABEL
Packager Mondelēz Group LLC
Generic Name
Product Class
Product Number
Application Number PART356
  • Active Ingredient

    <(per drop) Menthol 15 mg>

  • Purposes

    <Oral anesthetic>

  • Uses

    <temporarily relieves occasional minor irritation and pain associated with

    • sore throat
    • sore mouth>
  • 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.>

  • Stop use and ask a doctor if

    • 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

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

    <citric acid, eucalyptus oil, FDC blue 1, flavors, glucose syrup, potassium citrate, soy lecithin, sucrose, water>

  • Questions

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

  • OTC Principal Display Panel

    <NDC 12546-311-30 Halls Extra Strong Menthol Flavor 30ct bag>MM1

  • INGREDIENTS AND APPEARANCE
    HALLS  EXTRA STRONG MENTHOL
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-311
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol15 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (white with blue specks) Scoreno score
    ShapeOVALSize21mm
    FlavorMENTHOL (Extra Strong Menthol) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-311-3030 in 1 BAG; Type 0: Not a Combination Product08/08/2016
    2NDC:12546-311-0202 in 1 BAG; Type 0: Not a Combination Product08/08/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/08/2016
    Labeler - Mondelēz Group LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelēz Canada Inc.246791201manufacture(12546-311)

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