Label: ORIGINAL EXTRA STRONG ALL NATURAL FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT- menthol lozenge

  • NDC Code(s): 55711-064-03
  • Packager: Lofthouse of Fleetwood, Ltd.
  • 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 December 31, 2018

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

  • Active ingredient (in each lozenge)

    Menthol 10 mg

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  • PURPOSE

    Cough suppressant/oral anesthetic

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  • Uses

    temporarily relieves

    • cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants
    • occasional minor sore throat
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  • Warnings

    Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 2 years of age unless directed by a doctor.

    Keep out of reach of children.

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  • ASK DOCTOR

    Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • a persistent or chronic cough that lasts such as occurs with smoking, asthma, or emphysema
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  • WHEN USING

    When using this product

    do not use more than directed.

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  • STOP USE

    Stop use and ask a doctor if

    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
    • sore throat is severe, lasts more than 2 days, is accompanied or followed by fever, headache, rash, sweling, nausea, or vomiting

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding

    ask a health professional before use

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  • Directions


    • adults and children 2 years of age and over: allow 1 lozenge to dissolve slowly in the mouth
    • repeat every 2 hours as needed or as directed by a doctor
    • children under 2 years of age: ask a doctor
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  • Inactive ingredients

    capsicum, dextrin, eucalyptus oil, natural licorice, sugar, tragacanth

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  • Principal Display Panel

    Original Extra Strong

    All Natural

    Since Lofthouse's 1865

    Fisherman's Friend

    Menthol Cough Suppressant Lozenges

    40 Lozenges in 2 Convenient Packs of 20 Each

    Original Extra Strong 40 Count

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  • INGREDIENTS AND APPEARANCE
    ORIGINAL EXTRA STRONG ALL NATURAL FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT 
    menthol lozenge
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55711-064
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    CAPSICUM (UNII: 00UK7646FG)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LICORICE (UNII: 61ZBX54883)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    TRAGACANTH (UNII: 2944357O2O)  
    Product Characteristics
    Color brown (Light Brown) Score no score
    Shape OVAL Size 20mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55711-064-03 2 in 1 PACKAGE 08/10/2010
    1 20 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 08/10/2010
    Labeler - Lofthouse of Fleetwood, Ltd. (212605588)
    Establishment
    Name Address ID/FEI Business Operations
    Lofthouse of Fleetwood, Ltd. 212605588 manufacture(55711-064)
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