HALLSMELON SPLASH MELON SPLASH (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]

HALLSMELON SPLASH MELON SPLASH (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]
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NDC 12546-315-09
Set ID 779ae0f5-0dab-4972-9294-3d664ef34736
Category HUMAN OTC DRUG LABEL
Packager Mondelez Global LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • Active Ingredient

    <(in each drop) Menthol 3.1 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, persist 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 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

    • 15 calories per drop
    • contains: soy
  • Inactive Ingredients

    <citric acid, eucalyptus oil, FDC blue 1, FDC yellow 5 (tartrazine), 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>

  • Principal Display Panel

    <Halls Melon Splash US NDC 12546-315-09 and CA NDC 67238-315-09>MM1

  • INGREDIENTS AND APPEARANCE
    HALLSMELON SPLASH   MELON SPLASH
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-315
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.1 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorgreen (light green) Scoreno score
    ShapeSQUARESize21mm
    FlavorFRUIT (Melon Splash) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-315-0909 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/04/2014
    Labeler - Mondelez Global LLC (050964956)

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