Label: BURTS BEES THROAT SOOTHING- pectin lozenge

  • NDC Code(s): 0113-8004-22, 0113-8004-46
  • Packager: L. Perrigo Company
  • 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 May 22, 2023

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  • Active ingredient (in each throat pop)

    Pectin 10.5 mg

  • Purpose

    Oral demulcent

  • Uses

    •
    for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat
  • Warnings

    Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly

    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

    •
    children 3 years and older: allow one throat pop to dissolve slowly in mouth, child should be seated and under adult supervision
    •
    may be repeated as needed or as directed by a doctor
    •
    children under 3 years: ask a doctor
  • Other information

    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    citric acid, manuka honey, natural flavor, organic rice syrup, raspberry powder, sucrose, water

  • Questions or comments?

    1-800-864-9649

  • Package/Label Principal Display Panel

    3 + YEARS

    burt’s bees…KIDS…™

    throat soothing pops

    NOT ACTUAL SIZE

    Oral Demulcent | Pectin 10.5 mg/pop

    Helps Soothe Sore, Irritated Throats

    Made with 100% Natural Manuka Honey

    CHERRY

    No Synthetic Colors or Flavors

    NON-GMO

    15 Throat Pops

    throat soothing pops- image-1
    throat soothing pops-image-2
  • INGREDIENTS AND APPEARANCE
    BURTS BEES THROAT SOOTHING 
    pectin lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-8004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN10.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize20mm
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-8004-2215 in 1 BAG; Type 0: Not a Combination Product06/06/2021
    2NDC:0113-8004-4610 in 1 CARTON06/15/2021
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/06/2021
    Labeler - L. Perrigo Company (006013346)
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