Label: HALLS KIDS STRAWBERRY- menthol lozenge

  • NDC Code(s): 12546-337-01, 12546-337-10, 12546-337-11
  • 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 August 5, 2019

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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

    <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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