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

  • NDC Code(s): 55711-064-01, 55711-064-02, 55711-064-03, 55711-064-05
  • Packager: Lofthouse of Fleetwood, Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 27, 2024

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  • Drug Facts

  • Active ingredient (in each lozenge)

    Menthol 10 mg

  • Purpose

    Cough suppressant/oral anesthetic

  • Uses

    temporarily relieves

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

    Ask a doctor before use if you have

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

    When using this product
    do not use more than directed

    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, swelling, nausea, or vomiting

    If pregnant or breast-feeding, ask a health professional before use

    Keep out of reach of children.

  • 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

  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    FISHERMAN'S FRIEND ®

    ORIGINAL EXTRA STRONG

    Menthol Cough Suppressant Lozenges

    Cough Suppresant/Oral Anesthetic

    Manufactured by: Lofthouse of Fleetwood Ltd., Lancs, England

    Distributed by: Greenwood Brands, LLC. Buffalo-Niagara, NY 14225

    ffinfo@greenwoodg.com

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  • INGREDIENTS AND APPEARANCE
    ORIGINAL EXTRA STRONG ALL NATURAL FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55711-064
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CAPSICUM (UNII: 00UK7646FG)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LICORICE (UNII: 61ZBX54883)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    TRAGACANTH (UNII: 2944357O2O)  
    Product Characteristics
    Colorbrown (light brown) Scoreno score
    ShapeOVALSize20mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55711-064-0120 in 1 PACKET; Type 0: Not a Combination Product08/10/2010
    2NDC:55711-064-0238 in 1 BOX; Type 0: Not a Combination Product08/10/2010
    3NDC:55711-064-032 in 1 PACKAGE08/10/2010
    320 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:55711-064-052 in 1 PACKAGE; Type 0: Not a Combination Product08/10/201001/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/10/2010
    Labeler - Lofthouse of Fleetwood, Ltd. (212605588)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lofthouse of Fleetwood, Ltd.212605588manufacture(55711-064)
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