Label: COOL RELIEF ORAL ANESTHETIC- menthol lozenge

  • NDC Code(s): 63667-153-19, 63667-153-24, 63667-153-45
  • Packager: Ricola USA Inc.
  • 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 18, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

    Purpose

    Cough suppressant, Oral anesthetic

  • Active Ingredient (in each drop)

    Menthol, 8.3 mg

  • Uses

    temporarily relieves:

    • cough due to a cold or inhaled irritants
    • occasional minor irritation and pain due to sore throat or sore mouth
  • 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
  • Other Information

    protect from heat and moisture

  • Inactive Ingredients

    extracts of peppermint and a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), glycerin, invert sugar (fructose/dextrose), natural flavor, starch syrup, sugar

  • PRINCIPAL DISPLAY PANEL

    Image of Cool Relief MFP08S-86.jpg

  • INGREDIENTS AND APPEARANCE
    COOL RELIEF ORAL ANESTHETIC 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63667-153
    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
    FlavorMENTHOL (Icy Menthol) Imprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63667-153-1919 in 1 BAG; Type 0: Not a Combination Product06/01/2018
    2NDC:63667-153-2424 in 1 BAG; Type 0: Not a Combination Product06/01/2018
    3NDC:63667-153-4545 in 1 BAG; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/2018
    Labeler - Ricola USA Inc. (177265261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ricola Ag 485393768manufacture(63667-153)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!