Label: BREEZERS CREAMY STRAWBERRY- pectin lozenge

  • NDC Code(s): 12546-352-25, 12546-352-30, 12546-352-70
  • Packager: Mondelez Global LLC
  • 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 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

    • Contains: SOY.>

  • Inactive ingredients

    <beta carotene, citric acid, FDC blue 2, FDC red 40, flavors, glucose syrup, lactic acid, malic acid, potassium citrate, sodium chloride, soy lecithin, sucrose, titanium dioxide, water>

  • Questions

    <Call 1-800-524-2854, Monday to Friday, 9AM-5PM Eastern Time or visit our website at www.gethalls.com>

  • OTC Principal Display Panel

    Halls creamy strawberry 25ct

  • INGREDIENTS AND APPEARANCE
    BREEZERS  CREAMY STRAWBERRY
    pectin lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-352
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN7 mg
    Inactive Ingredients
    Ingredient NameStrength
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    MALIC ACID (UNII: 817L1N4CKP)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (White with red stripe) Scoreno score
    ShapeOVALSize22mm
    FlavorSTRAWBERRY (Creamy Strawberry) Imprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12546-352-2525 in 1 BAG; Type 0: Not a Combination Product03/13/2019
    2NDC:12546-352-3030 in 1 BAG; Type 0: Not a Combination Product03/13/201909/16/2022
    3NDC:12546-352-7070 in 1 BAG; Type 0: Not a Combination Product05/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/03/2016
    Labeler - Mondelez Global LLC (050964956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mondelez Canada Inc246791201manufacture(12546-352)
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