Label: RICOLA MAX NASAL CARE COOL MENTHOL- menthol 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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  • Drug Facts

    Purpose

    Oral anesthetic

  • Active Ingredient (in each drop)

    Menthol, 15.3 mg

  • Uses

    temporarily relieves occasional minor irritation and pain associated with:

    • sore mouth
    • sore throat
  • Warnings

    ​Sore throat warnings:

    • if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These may be serious.
  • Keep out of reach of children.


  • Directions

    • adults and children 6 years and older:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor.
    • children under 6 years: ask a doctor
    • do not bite or chew
  • Other Information

    Store in a dry place

  • Inactive Ingredients

    extract of lemon balm and the Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), colors (carrot, spirulina), flavors (lemon-thyme, peppermint), starch syrup, sugar

  • PRINCIPAL DISPLAY PANEL

    Image of Cropped 9014328_US_NEO_US-MAX_Nasal Cool Menthol_34ct_Film_low - Flat File.jpg

  • INGREDIENTS AND APPEARANCE
    RICOLA MAX NASAL CARE COOL MENTHOL 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54305-206
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15.3 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize24mm
    FlavorMENTHOLImprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54305-206-3434 in 1 BAG; Type 0: Not a Combination Product03/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/01/2022
    Labeler - Ricola Ag (480227248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ricola Ag 485393768manufacture(54305-206)
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