Label: HALLSSUGAR FREE EXTRA SUGAR FREE EXTRA STRONG MENTHOL- menthol lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 7, 2014

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  • Active Ingredients

    <(in each drop) 18 mg>

  • Purposes

    <Oral Anesthetic>

  • Uses

    <temporarily relieves occasional minor irritation and pain associated with

    • sore throat
    • sore mouth>
  • Warnings

    <Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headached, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.>

  • Stop Use and Ask a Doctor if

    • sore mouth does not improve in 7 days
    • irritation, pain, or redness persists or worsens
  • Keep out of reach of children

  • 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

    • phenylketonurics:  contains phenylalanine 2 mg per drop
    • excessive consumption may have a laxative effect
    • 5 calories per drop
    • contains: soy
  • Inactive ingredients

    <acesulfame potassium, aspartame, citric acid, eucalyptus oil, FDC blue 1, flavors, isomalt, sodium carboxymethylcellulose, 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

    <Halls Sugar Free Extra Strong Menthol Flavor 9 drops package US NDC 12546-314-09 and CA NDC 67238-314-09>MM1

  • INGREDIENTS AND APPEARANCE
    HALLSSUGAR FREE EXTRA   SUGAR FREE EXTRA STRONG MENTHOL
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-314
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL18 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOMALT (UNII: S870P55O2W)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (white with blue speckles) Scoreno score
    ShapeSQUARESize21mm
    FlavorMENTHOL (Sugar Free Extra Strong) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-314-0909 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/04/2014
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc.246791201manufacture(12546-314)
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