Label: THE ORIGINAL NATURAL HERB COUGH DROPS- menthol lozenge

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated February 10, 2020

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  • Drug Facts

    Purpose

    Cough suppressant, Oral pain reliever

  • Active Ingredient (in each drop)

    Menthol, 5.3 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
  • Inactive Ingredients

    color (caramel), extract of a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), natural flavor, starch syrup, sugar
  • PRINCIPAL DISPLAY PANEL

    Image of STG_ETGD_RKZ_37G_US_9008618_Final.jpg

  • INGREDIENTS AND APPEARANCE
    THE ORIGINAL NATURAL HERB COUGH DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54305-923
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.3 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    CARAMEL (UNII: T9D99G2B1R)  
    Product Characteristics
    Colorbrown (NUT BROWN) Scoreno score
    ShapeRECTANGLESize16mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54305-923-1010 in 1 PACKAGE; Type 0: Not a Combination Product01/01/1942
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/1942
    Labeler - Ricola Ag (480227248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ricola Ag 485393768manufacture(54305-923)