Label: THROAT BALM CARAMEL PECTIN- 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 January 18, 2023

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  • ACTIVE INGREDIENT

    Active ingredient (in two drops)

    Pectin 7.6 mg

  • PURPOSE

    Purpose

    Oral demulcent

  • INDICATIONS & USAGE

    Uses temporarily relieves:

    occasional minor irritation and pain associated with

    • sore mouth
    • sore throat
  • WARNINGS

    Warnings

    Do not use

    • ​in children under 6 years of age unless directed by a doctor.
  • ASK DOCTOR

    Stop use and ask a doctor if

    • sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.
    • sore mouth symptoms do not improve in 7 days.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 6 years and older: dissolve 2 drops (one at a time) slowly in the mouth. Do not bite or chew. Repeat every 2 hours as needed or as directed by a doctor
    • children under 6 years: ask a doctor
  • STORAGE AND HANDLING

    Other Information

    protect from heat and moisture

  • INACTIVE INGREDIENT

    Inactive Ingredients: Caramel sugar syrup; cocoa butter; emulsifier (sunflower lecithin), extracts of bee balm, Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme) and rooibos; glucose syrup; glucose-fructose syrup; honey; humectant (glycerine); natural flavoring (caramel, echinacea purpurea fresh plant pressed juice powder, honey, menthol, peppermint, vanilla); salt; sugar

  • PRINCIPAL DISPLAY PANEL

    Image of BT HERMELECH 34ct US 9014779 low.jpg

  • INGREDIENTS AND APPEARANCE
    THROAT BALM CARAMEL PECTIN 
    pectin lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63667-301
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN3.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE CARAMEL (UNII: D8GMM4517Q)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeOVALSize24mm
    FlavorCARAMELImprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63667-301-3434 in 1 BAG; Type 0: Not a Combination Product11/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/01/2022
    Labeler - Ricola USA Inc. (177265261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ricola Ag485393768manufacture(63667-301)
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