Label: MEYER LEMON AND HONEY-COUGH RELIEF- 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 16, 2020

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  • ACTIVE INGREDIENT

    Medicinal Ingredients:

    Each lozenge contains:

    l-Menthol 5.97mg

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

  • INDICATIONS & USAGE

    Recommended Use

    For the temporary relief of coughs and sore throat.

  • 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 for 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, Organic Honey, Natural Lemon Flavour, Organic Tumeric

  • PURPOSE

    Antitussif

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach children

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    MEYER LEMON AND HONEY-COUGH RELIEF 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70084-613
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.97 mg
    Inactive Ingredients
    Ingredient NameStrength
    CURCUMA LONGA WHOLE (UNII: W5488JUO8U)  
    BARLEY MALT SYRUP (UNII: 22P8DKP670)  
    MEYER LEMON (UNII: ZD6P2CXI88)  
    ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)  
    SUGARCANE (UNII: 81H2R5AOH3)  
    HONEY (UNII: Y9H1V576FH)  
    Product Characteristics
    ColoryellowScorescore with uneven pieces
    ShapeROUNDSize23mm
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70084-613-0118 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 Candy005086855manufacture(70084-613)
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