Label: SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS- menthol lozenge 

  • Label RSS
  • NDC Code(s): 54305-802-19, 54305-802-24
  • Packager: Ricola Ag
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/13

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

  • Drug Facts

    Purpose

    Cough suppressant, Oral anesthetic

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  • Active Ingredient (in each drop)

    Menthol, 4.8 mg

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  • Uses

    temporarily relieves:

    • cough due to a cold or inhaled irritants
    • occasional minor irritation and pain due to sore throat or sore mouth
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  • 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.
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  • Ask doctor before use if you have

    • persistent chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by excessive phlegm (mucus)
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  • 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
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  • Keep out of reach of children.
  • Directions

    • adults and children 6 years and older:  dissolve 2 drops (one at a time) slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
    • children under 6 years: ask a doctor
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  • Other Information

    • Phenylketonurics: contains phenylalanine 1 mg per drop
    • excessive use may have a laxative effect
    • store in a dry place
    • product may be useful for diabetics on the advice of a doctor

    Exchange information:   2 Drops = FREE Exchange

                                                    7 Drops = 1 Fruit

    Dietary exchanges based on Exchange Lists for Diabetics

    © 2008 American Diabetes Association, American Dietetic Association

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  • Inactive Ingredients

    aspartame, color (caramel), extract of a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), isomalt, natural flavor, sorbitol

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  • INGREDIENTS AND APPEARANCE
    SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS 
    menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54305-802
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 4.8 mg
    Inactive Ingredients
    Ingredient Name Strength
    ISOMALT  
    SORBITOL  
    ASPARTAME  
    CARAMEL  
    Product Characteristics
    Color brown (DEER BROWN) Score no score
    Shape OVAL Size 24mm
    Flavor MENTHOL Imprint Code R
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54305-802-19 19 in 1 BAG
    2 NDC:54305-802-24 24 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 04/12/1942
    Labeler - Ricola Ag (480227248)
    Establishment
    Name Address ID/FEI Business Operations
    Ricola Ag 485393768 manufacture(54305-802)
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