Label: DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC- menthol lozenge

  • NDC Code(s): 63667-234-19, 63667-234-26, 63667-234-75
  • 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

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  • 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,
    • do not use in children under 6 years of age unless directed by a doctor.
  • Ask doctor before use if you have

    • persistent chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by excessive phlegm (mucus)
  • Stop use and ask a doctor if

    • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  These could be signs of a serious condition.
    • sore mouth does not improve in 7 days
    • irritation, pain, or redness persists or worsens
  • 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

    protect from heat and moisture

  • Inactive Ingredients

    citric acid, extract of a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), glycerin, honey, lemon juice concentrate, natural color (beta-carotene), natural flavors, starch syrup, sugar

  • PRINCIPAL DISPLAY PANEL

    Image of DualActHoneyLem19ct.jpg

  • INGREDIENTS AND APPEARANCE
    DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63667-234
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8.3 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HONEY (UNII: Y9H1V576FH)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize24mm
    FlavorHONEYImprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63667-234-1919 in 1 PACKAGE; Type 0: Not a Combination Product05/01/2015
    2NDC:63667-234-2626 in 1 PACKAGE; Type 0: Not a Combination Product05/01/2015
    3NDC:63667-234-75175 in 1 PACKAGE; Type 0: Not a Combination Product01/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2015
    Labeler - Ricola USA Inc. (177265261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ricola Ag 485393768manufacture(63667-234)
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