Label: HALLS GREEN APPLE- menthol lozenge

  • NDC Code(s): 12546-118-30, 12546-118-80
  • Packager: Mondelez Global LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2024

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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, 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 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

    • 10 Calories per drop
    • Contains: SOY.
  • Inactive ingredients

    beta carotene, citric acid, eucalyptus oil, FD&C blue 1, flavors, glucose syrup, malic acid, potassium
    citrate, soy lecithin, sucrose, water

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Green Apple Art

  • INGREDIENTS AND APPEARANCE
    HALLS  GREEN APPLE
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-118
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SUCROSE (UNII: C151H8M554)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    MALIC ACID (UNII: 817L1N4CKP)  
    SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize21mm
    FlavorAPPLEImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-118-8080 in 1 BAG; Type 0: Not a Combination Product09/24/2024
    2NDC:12546-118-3030 in 1 BAG; Type 0: Not a Combination Product09/24/202411/20/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/24/2024
    Labeler - Mondelez Global LLC (091849786)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc246791201manufacture(12546-118)
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