Label: NATURAL LEMON MINT HERB THROAT DROPS- menthol lozenge

  • NDC Code(s): 63667-957-24, 63667-957-30
  • Packager: Ricola USA Inc.
  • 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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  • Drug Facts

    Purpose

    Oral anesthetic

  • Active Ingredient (in each drop)

    Menthol, 1.5 mg

  • Uses

    temporarily relieves occasional minor irritation and pain associated with:

    • sore mouth
    • sore throat
  • Warnings

    Do not use

    • in children under 6 years of age unless directed by a 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.


  • Directions

    • adults and children 6 years and older:  dissolve 2 drops (one at a time) slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
    • children under 6 years: ask a doctor
  • Other Information

    Store in a dry place

  • Inactive Ingredients

    citric acid, extracts of lemon balm and a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), natural color (beta-carotene), natural flavors, starch syrup, sugar
  • PRINCIPAL DISPLAY PANEL

    Image of Lemon Mint.jpg

  • INGREDIENTS AND APPEARANCE
    NATURAL LEMON MINT HERB THROAT DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63667-957
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Coloryellow (GOLDEN YELLOW) Scoreno score
    ShapeOVALSize24mm
    FlavorLEMON (LEMON MINT) Imprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63667-957-2424 in 1 BAG; Type 0: Not a Combination Product01/01/1942
    2NDC:63667-957-3030 in 1 BAG; Type 0: Not a Combination Product01/01/194201/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/01/1942
    Labeler - Ricola USA Inc. (177265261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ricola Ag480227248manufacture(63667-957)
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