Label: MEYER LEMON AND HONEY-COUGH RELIEF LOZENGES (ORAL ANESTHETIC)- 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

    (In each lozenge)

    Organic Menthol 5mg

  • PURPOSE

    Antitussive (Cough Suppressant) / Oral Anesthetic

  • WARNINGS

    Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 5 years of age unless directed by a physician.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor before use if you have:

    - persistent or chronic cough as occurs with smoking, asthma, or emphysema.

    - cough that occurs with excessive phlegm (mucus).

  • STOP USE

    - cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

    - sore mouth symptoms do not improve in 7 days.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Adults and children 5 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor. Children under 5years of age: ask a doctor.

  • OTHER SAFETY INFORMATION

    Store in a cool, dry place.

  • INACTIVE INGREDIENT

    Organic Brown Rice Syrup, Organic Cane Syrup, Organic Honey, Natural Meyer Lemon Flavor and Other Natural Flavors, Organic Slippery Elm Bark Powder, and Organic Tumeric.

  • INDICATIONS & USAGE

    - cough due to minor throat and bronchial irritation occurring with the common cold and inhaled irritation,

    - occasional minor irritation, pain, sore mouth, and sore throat.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    MEYER LEMON AND HONEY-COUGH RELIEF LOZENGES (ORAL ANESTHETIC) 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70084-614
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MEYER LEMON (UNII: ZD6P2CXI88)  
    CURCUMA LONGA WHOLE (UNII: W5488JUO8U)  
    BARLEY MALT SYRUP (UNII: 22P8DKP670)  
    SUGARCANE (UNII: 81H2R5AOH3)  
    HONEY (UNII: Y9H1V576FH)  
    ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)  
    Product Characteristics
    ColoryellowScorescore with uneven pieces
    ShapeROUNDSize23mm
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70084-614-0118 in 1 BOX; Type 0: Not a Combination Product01/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/15/2020
    Labeler - Quantum, Inc. (044806305)
    Establishment
    NameAddressID/FEIBusiness Operations
    Primrose Candy Company005086855manufacture(70084-614)
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