HALLS SUGAR FREE BLACK CHERRY (MENTHOL) LOZENGE [KRAFT FOODS GLOBAL, INC.]

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HALLS SUGAR FREE BLACK CHERRY (MENTHOL) LOZENGE [KRAFT FOODS GLOBAL, INC.]
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NDC 12546-107-50
Set ID 743ed3b6-0cb1-4762-b880-92c6a0745631
Category HUMAN OTC DRUG LABEL
Packager Kraft Foods Global, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active Ingredient


    (in each drop) Menthol 3.7 mg
  • Purpose

    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

    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

    • phenylketonurics: contains phenylalanine 1 mg per drop
    • excessive consumption may have a laxative effect
    • 5 calories per drop
    • Contains: soy.
  • Inactive ingredients


    acesulfame potassium, aspartame, eucalyptus oil, FDC blue 1, FDC red 40, flavors, isomalt, sodium carboxycellulose, soy lecithin, 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
    12546-107-50
    Halls Sugar Free Black Cherry
    50 Drops Bottle
    image of bottle label
  • INGREDIENTS AND APPEARANCE
    HALLS  SUGAR FREE BLACK CHERRY
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-107
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol3.7 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ISOMALT (UNII: S870P55O2W)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (RED) Scoreno score
    ShapeOVALSize18mm
    FlavorCHERRY (BLACK CHERRY) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-107-5050 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2011
    Labeler - Kraft Foods Global, Inc. (039010590)
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