Label: HALLS SUGAR FREE HONEY LEMON- menthol lozenge

  • NDC Code(s): 12546-347-03, 12546-347-24
  • Packager: Mondelez Global LLC
  • 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 October 4, 2022

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  • Active ingredient

    <(per drop) Menthol 2.5 mg>

  • Purposes

    <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, persist 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. 

    In case of overdose, get medical help or contact a Poison Control Center right away

  • 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

    • excessive consumption may have a laxative effect
    • <5 calories per drop
    • Contains: SOY.

  • Inactive ingredients

    <beta carotene, citric acid, eucalyptus oil, flavors, isomalt, soy lecithin, sucralose, water>

  • Questions

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

  • OTC Principal Display Panel

    Halls Minis sugar free honey lemon 24ct frontHalls minis sugar free honey lemon 24ct back

  • INGREDIENTS AND APPEARANCE
    HALLS  SUGAR FREE HONEY LEMON
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-347
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ISOMALT (UNII: S870P55O2W)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize9mm
    FlavorHONEY (Honey Lemon) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-347-0311667 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product10/21/202010/03/2022
    2NDC:12546-347-2424 in 1 PACKAGE; Type 0: Not a Combination Product10/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/21/2020
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    MSI Express Inc117942991pack(12546-347)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc246791201manufacture(12546-347)
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