Label: HALLS SUGAR FREE MOUNTAIN MENTHOL- menthol lozenge

  • NDC Code(s): 12546-724-01, 12546-724-70, 12546-724-98
  • Packager: Mondelez Global LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 29, 2026

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  • Active Ingredient

    (per drop) Menthol 5.8 mg

  • Purposes

    Cough Suppressant, Oral Anesthetic

  • Uses

    temporarily relieves:

    • cough due to a cold
    • occasional minor irritation or sore throat
  • Warnings

    Sore throat warnings: 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.

    .

  • 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, eucalyptus oil, flavors, isomalt, sodium carboxymethylcellulose, soy lecithin, water>

  • Questions?

    <Call 1-800-524-2854, Monday to Friday2, 9 AM - 6 PM Eastern Time or visit our website atwww.gethalls.com>

  • OTC Principal Display Panel

    SF Mountain Menthol.jpg

  • INGREDIENTS AND APPEARANCE
    HALLS  SUGAR FREE MOUNTAIN MENTHOL
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-724
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    WATER (UNII: 059QF0KO0R)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ISOMALT (UNII: S870P55O2W)  
    Product Characteristics
    Colorwhite (CLEAR) Scoreno score
    ShapeOVALSize21mm
    FlavorMENTHOL (MOUNTAIN MENTHOL) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-724-01150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product04/29/2026
    2NDC:12546-724-7070 in 1 BAG; Type 0: Not a Combination Product04/29/2026
    3NDC:12546-724-98225 in 1 JAR; Type 0: Not a Combination Product04/29/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/29/2026
    Labeler - Mondelez Global LLC (091849786)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc.246791201manufacture(12546-724)
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