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

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 October 4, 2022

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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 not finalpart35603/24/2019
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc246791201manufacture(12546-151)
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