Label: HALLS SUGAR FREE BLACK CHERRY- 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 April 13, 2011

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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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