HALLS KIDS STRAWBERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]

HALLS KIDS STRAWBERRY (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]
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NDC 12546-337-01, 12546-337-10
Set ID f1eaafe3-2065-4961-af03-bb6bcea331a3
Category HUMAN OTC DRUG LABEL
Packager Mondelez Global LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • 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

    <citric acid, FD&C red 40, flavors, glucose syrup, potassium citrate, 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 12546-337-10 Halls Kids Strawberry 10ct Bag>

    MM1

  • INGREDIENTS AND APPEARANCE
    HALLS KIDS  STRAWBERRY
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-337
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize20mm
    FlavorSTRAWBERRYImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-337-1010 in 1 BAG; Type 0: Not a Combination Product07/26/2019
    2NDC:12546-337-1110 in 1 CARTON; Type 0: Not a Combination Product08/05/2019
    3NDC:12546-337-011 in 1 BAG; Type 0: Not a Combination Product07/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/26/2019
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    BestCo Inc.002149136manufacture(12546-337)

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