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

  • NDC Code(s): 55711-064-05
  • 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 June 25, 2021

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  • Active ingredient (in each lozenge)

    Menthol 10 mg

  • Purpose

    Cough suppressant/oral anesthetic

  • Uses

    temporarily relieves

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

    Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. If sore throat is severe or persists more than 2 days accompanied by headache, nausea, and vomiting, contact a doctor right away. If sore mouth symptoms do not improve in 7 days, see your dentist of doctor promptly.

    Keep out of reach of children.

  • WHEN USING

    When using this product do not use more than directed

  • PREGNANCY OR BREAST FEEDING

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

  • Directions


    • adults and children 2 to under 12 years of age: allow lozenge to dissolve slowly in the mouth
    • may be repeated every hour as needed for cough, or every 2 hours as needed for sore throat, or as directed by a doctor
    • children under 2 years of age: consult a doctor
  • Inactive ingredients

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

  • Principal Display Panel

    Original

    Extra

    Strong

    Trial Size

    Since Lofthouse's 1865

    Fisherman's Friend

    Menthol Cough Suppressant Lozenges

    Cough Suppressant/Oral Anesthetic

    No Artificial Flavors or Ingredients

    2 Lozenges

    Manufactured by:

    Lofthouse of Fleetwood Ltd., Lancs., England

    Distributed by: Pez Candy Inc.

    35 Prindle Hill Road, Orange, CT 06477

    www.fishermansfriend.com

    Original Extra Strong Trial Size

  • 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:55711-064-052 in 1 PACKET; Type 0: Not a Combination Product09/08/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/08/2010
    Labeler - Lofthouse of Fleetwood, Ltd. (212605588)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lofthouse of Fleetwood, Ltd.212605588manufacture(55711-064)
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