Label: HALLS PLUS STRAWBERRY- menthol lozenge

  • 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 July 25, 2013

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  • Active Ingredient

    <(in each drop) Menthol 2.7 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 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

    • 15 calories per drop
    • contains: soy
  • Inactive ingredients

    <FDC red40, flavors, glucose syrup, glycerin, partially hydrogenated cottonseed oil, 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>

  • OTC Principal Display Panel

    OTC PDPEnter section text here<USNDC 12546-985-25 and CA NDC 67238-985-25 Halls Plus Icy Syrup Center Strawberry Flavor 25 drops bag>

  • INGREDIENTS AND APPEARANCE
    HALLS  PLUS STRAWBERRY
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-985
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol2.7 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (Red) Scoreno score
    ShapeOVALSize22mm
    FlavorSTRAWBERRY (Plus Strawberry) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-985-2525 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2013
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc.246791201manufacture(12546-985)
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