Label: THE ORIGINAL NATURAL HERB COUGH DROPS- menthol lozenge

  • 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 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)
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