Label: HALLS BREEZERS SUGAR FREE COOL BERRY- pectin lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2024

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  • Active Ingredient

    (per drop) Pectin 7 mg

  • Purpose

    <Oral Demulcent>

  • Uses

    <temporarily relieves the following symptoms associated with sore mouth and sore throat:

    • minor discomfort
    • irritated areas>
  • 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.>

  • Stop use and ask a doctor if

    • 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 or 2 drops (one at a time) slowly in the mouth.  Repeat as needed.
    • children under 5 years: ask a doctor
  • Other information

    • phenylketonurics: contains phenylalanine 2 mg per drop
    • excessive consumption may have a laxative effect
    • 10 calories per drop
    • Contains: SOY.
  • Inactive ingredients

    acesulfame potassium, aspartame, citric acid, FDC blue 2, FDC red 40, flavors, isomalt, malic acid, maltitol syrup, potassium citrate, soy lecithin, titanium dioxide, 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 12546-720-20 Halls SF Cool Berry 20ct bag>

  • INGREDIENTS AND APPEARANCE
    HALLS  BREEZERS SUGAR FREE COOL BERRY
    pectin lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-720
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN7 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ISOMALT (UNII: S870P55O2W)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MALTITOL (UNII: D65DG142WK)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (red and white) Scoreno score
    ShapeOVALSize21mm
    FlavorBERRY (Cool Berry) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-720-2020 in 1 BAG; Type 0: Not a Combination Product05/27/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02205/27/2019
    Labeler - Mondelez Global LLC (091849786)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc246791201manufacture(12546-720)
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