Label: HALLS BREEZERS SUGAR FREE COOL BERRY- pectin lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 20, 2023

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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 not finalpart35605/27/2019
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc246791201manufacture(12546-720)
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