Label: HALLSMELON SPLASH MELON SPLASH- menthol lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 4, 2014

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  • 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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