Label: HALLS 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 March 8, 2013

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  • Active Ingredient

    (in each drop) Menthol 7 mg 
  • Purposes

    Cough Suppressant, Oral Anesthetic
  • Uses

    • 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 1 drop 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

    eucalyptus oil, FDC blue 2, FDC red 40, flavors, glucose syrup, soy lecithin, sucralose, sucrose, 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

    Enter section text hereNDC 12546-165-09 Halls Cherry 9 drops packageOTC Principal Display Panel 9 stick

  • INGREDIENTS AND APPEARANCE
    HALLS  CHERRY
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-165
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol7 mg
    Inactive Ingredients
    Ingredient NameStrength
    Eucalyptus oil (UNII: 2R04ONI662)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (red) Scoreno score
    ShapeSQUARESize21mm
    FlavorCHERRY (Cherry) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-165-0909 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2013
    Labeler - Mondelēz Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelēz Canada Inc.246791201manufacture(12546-165)
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