Label: SUGAR FREE HONEY-LEMON FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT- menthol lozenge

  • NDC Code(s): 55711-071-01, 55711-071-02, 55711-071-03, 55711-071-04
  • 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)

    Active ingredient (in each lozenge)

    Menthol 5.52 mg

  • Purpose

    Cough suppressant/oral anesthetic.

  • Uses

    temporarily relieves • occasional minor sore throat • cough due to minor throat and bronchial irritation occuring 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 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

    When using this product do not use more than directed.

    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, swelling, nausea, or vomiting.

    Pregnant or Breast Feeding

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

    Keep Out of Reach of Children

    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

    Inactive ingredients acesulfame K, citric acid, honey lemon flavor, magnesium stearate, sorbitol, sucralose.

  • PRINCIPAL DISPLAY PANEL

    FISHERMAN'S FRIEND

    HONEY-LEMON

    Menthol Cough Suppressant/Oral Anesthetic

    SUGAR FREE

    40 CT

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

    Distributed by: Greenwood Brands, LLC, Buffalo-Niagra, NY 14225

    ffinfo@greenwoodg.com

    label

  • INGREDIENTS AND APPEARANCE
    SUGAR FREE HONEY-LEMON FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55711-071
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.52 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SORBITOL (UNII: 506T60A25R)  
    ACESULFAME (UNII: MA3UYZ6K1H)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Colorwhite (White lozenge with honey-colored spots) Scorescore with uneven pieces
    ShapeOVAL (Oval lozenge 22mm x 13mm) Size20mm
    FlavorLEMON (Honey-Lemon Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55711-071-012 in 1 PACKET; Type 0: Not a Combination Product05/02/2019
    2NDC:55711-071-032 in 1 BAG05/02/2019
    220 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:55711-071-0220 in 1 PACKET; Type 0: Not a Combination Product05/02/2019
    4NDC:55711-071-042 in 1 BOX05/02/2019
    420 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/02/2019
    Labeler - Lofthouse of Fleetwood, Ltd. (212605588)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lofthouse of Fleetwood, Ltd.212605588manufacture(55711-071)
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