SUGAR FREE REFRESHING MINT FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT- menthol lozenge 
Lofthouse of Fleetwood, Ltd.

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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Mint Fisherman's Friend

Drug Facts

Active ingredient (in each lozenge)

Menthol 3 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 2 lozenges 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

magnesium stearate, peppermint flavour, sorbitol, sucralose

Sugar Free

Fisherman's Friend ®

Refreshing Mint

Menthol Cough Suppressant Lozenges

Cough Suppressant/Oral Anesthetic

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

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

ffinfo@greenwoodg.com

20 Lozenges

label

SUGAR FREE REFRESHING MINT FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55711-066
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 mg
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize20mm
FlavorMINT (Refreshing Mint) Imprint Code FF
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55711-066-0120 in 1 PACKET; Type 0: Not a Combination Product08/10/201011/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/10/201011/30/2023
Labeler - Lofthouse of Fleetwood, Ltd. (212605588)
Establishment
NameAddressID/FEIBusiness Operations
Lofthouse of Fleetwood, Ltd.212605588manufacture(55711-066)

Revised: 11/2022
 
Lofthouse of Fleetwood, Ltd.