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Halls (Kraft Foods Global, Inc.)

Available Formats

Dosage Form Package Information Links
LOZENGE 20 LOZENGE in 1 BAG (12546-105-20) Label Information
LOZENGE 2 LOZENGE in 1 BAG (12546-105-02) Label Information

Complete Halls Information

  • Active Ingredient

    <(in each drop) Menthol 5 mg>

  • Purposes

    <Cough Suppressant, Oral Anesthetic>

  • Uses

    • 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 persist or worsens

  • Keep out of reach of children

    Enter section text here

  • 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

    • 15 calories per drop
    • contains: soy

  • Inactive ingredients

    <caramel color, FDC blue 1, FDC red 40, FDC yellow 5 (tartrazine), flavors, glucose syrup, glycerin, partially hydrogenated cottonseed oil, 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>

  • OTC Principal Display Panel

    <NDC 12546-105-20 Halls Warm Ups Mocha Mint 20 drops bag>

    OTC Principal Display Panel

    menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-105
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARAMEL (UNII: T9D99G2B1R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color brown (LIGHT BROWN) Score no score
    Shape OVAL Size 22mm
    Flavor MINT (MOCHA MINT FLAVOR) Imprint Code H
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12546-105-20 20 in 1 BAG
    2 NDC:12546-105-02 2 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/01/2013
    Labeler - Mondelez Global LLC (050964956)
    Name Address ID/FEI Business Operations
    Mondelez Canada Inc. 246791201 manufacture(12546-105)