Label: HALLS KIDS HONEY APPLE- menthol lozenge

  • NDC Code(s): 12546-350-01, 12546-350-10, 12546-350-11
  • 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 November 30, 2021

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  • Active Ingredient

    (per pop) Menthol 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, persists for more than 2 days, is accompanied by fever, headache, rash, swelling, 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 pop slowly in the mouth. Repeat every 2 hours as needed.
    • children under 5 years: ask a doctor
  • Other information

    • 25 calories per pop
  • Inactive ingredients

    flavors, glucose syrup, honey, 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

    <NDC 12546-350-10 Halls Kids Honey Apple Bag 10 ct>

    MM1

  • INGREDIENTS AND APPEARANCE
    HALLS KIDS   HONEY APPLE
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-350
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    HONEY (UNII: Y9H1V576FH)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Coloryellow (pale yellow) Scoreno score
    ShapeROUNDSize20mm
    FlavorHONEY (Honey Apple) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-350-1010 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    2NDC:12546-350-1110 in 1 CARTON; Type 0: Not a Combination Product03/30/2020
    3NDC:12546-350-01800 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/202005/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/30/2020
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    BestCo Inc.002149136manufacture(12546-350)
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