Label: HALLS SUGAR FREE WATERMELON- 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 December 12, 2021

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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, persist 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.

    In case of overdose, get medical help or contact a Poison Control Center right away

  • 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

    • phenylketonurics: contains phenylalanine 0.5 mg per drop
    • excessive consumption may have a laxative effect
    • <5 calories per drop
    • Contains: SOY.
  • Inactive ingredients

    acesulfame potassium, aspartame, citric acid, eucalyptus oil, FD&C red 40, flavors (includes cinnamon), isomalt, soy lecithin, water

  • Questions

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

  • OTC Principal Display Panel

    <NDC 12546-351-24 Halls Sugar Free Watermelon 24ct>

    <NDC 12546-349-24 Halls Sugar Free Watermelon 24ct<NDC 12546-349-24 Halls Sugar Free Watermelon 24ct

  • INGREDIENTS AND APPEARANCE
    HALLS  SUGAR FREE WATERMELON
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-351
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ISOMALT (UNII: S870P55O2W)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize9mm
    FlavorWATERMELONImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-351-2424 in 1 PACKAGE; Type 0: Not a Combination Product12/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/13/2021
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    MSI Express, Inc117973852pack(12546-351)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc246791201manufacture(12546-351)
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