Label: BREEZERS COOL BERRY- pectin lozenge

  • NDC Code(s): 12546-151-25, 12546-151-30, 12546-151-70
  • Packager: Mondelez Global LLC
  • 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

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

  • 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

    <

    • 15 calories per drop
    • Contains: SOY.>
  • Inactive ingredients

    <citric acid, FDC blue 2, FDC red 40, flavors, glucose syrup, malic acid, potassium citrate, soy lecithin, sucrose, titanium dioxide, 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

    Halls cool berry 25ct

  • INGREDIENTS AND APPEARANCE
    BREEZERS  COOL BERRY
    pectin lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-151
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN7 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALIC ACID (UNII: 817L1N4CKP)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    Product Characteristics
    Colorred (red with white stripe) Scoreno score
    ShapeOVALSize22mm
    FlavorBERRY (Cool Berry) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-151-2525 in 1 BAG; Type 0: Not a Combination Product03/24/2019
    2NDC:12546-151-7070 in 1 BAG; Type 0: Not a Combination Product03/24/2019
    3NDC:12546-151-3030 in 1 BAG; Type 0: Not a Combination Product03/24/201909/16/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02203/24/2019
    Labeler - Mondelez Global LLC (091849786)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc246791201manufacture(12546-151)
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