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

  • NDC Code(s): 55711-064-01
  • 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.

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Updated May 12, 2021

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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

  • PRINCIPAL DISPLAY PANEL

    FISHERMAN'S FRIEND ®

    ORIGINAL EXTRA STRONG

    Menthol Cough Suppressant Lozenges

    Cough Suppresant/Oral Anesthetic

    20 Lozenges

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

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

    ffinfo@greenwoodg.com

    label

  • 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/10/2010
    Labeler - Lofthouse of Fleetwood, Ltd. (212605588)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lofthouse of Fleetwood, Ltd.212605588manufacture(55711-064)
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