Label: BING CHERRY COUGH ANTITUSSIF RELIEF ANTITUSSIF- menthol lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 10, 2023

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  • ACTIVE INGREDIENT

    Medicinal Ingredients:

    Each lozenge contains:

    I-Menthol 5.97mg

    Organic Slippery Elm Bark Pwder (Ulmus rubra, Stem bark inner) 10mg

  • PURPOSE

    Antitussif

  • DOSAGE & ADMINISTRATION

    Recommended Dose:

    Adults and children 6 years and over. Dissolve one lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor.

  • WARNINGS

    Cautions & Warnings:

    - If sore throat symptoms are severe or persist more than 2 days consult a doctor.

    - If cough worsens, persists more than 7 days or is accompanied by high fever consult a doctor.

  • INACTIVE INGREDIENT

    Non-Medicinal Ingredients:

    Organic Brown Rice Syrup, Organic Sugarcane juice, Beet juice concentrate, Natural Cherry Fruit Juice Concentrate, Organic honey.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Recommended Use

    For the temporary relief of coughs and sore throat.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BING CHERRY COUGH ANTITUSSIF RELIEF  ANTITUSSIF
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70084-612
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    BEET JUICE (UNII: IOZ32L9H3O)  
    CHERRY JUICE (UNII: 4XTQ10247Y)  
    HONEY (UNII: Y9H1V576FH)  
    ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)  
    SUGARCANE (UNII: 81H2R5AOH3)  
    BARLEY MALT SYRUP (UNII: 22P8DKP670)  
    Product Characteristics
    ColorredScorescore with uneven pieces
    ShapeROUNDSize23mm
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70084-612-0118 in 1 BOX; Type 0: Not a Combination Product12/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/11/2019
    Labeler - Quantum Inc. (044806305)
    Establishment
    NameAddressID/FEIBusiness Operations
    Primrose Candy Company005086855manufacture(70084-612)
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