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.

----------

066-02 (38 lozenge)

Active ingredient (in each lozenge)

Menthol 3 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

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.

Keep out of reach of children.

Ask a doctor before use if you have

  • 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

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

Other Informationwe

Phenylketonurics: Contains Phenylalanine 0.45 mg Per Lozenge

Inactive ingredients

aspartame, magnesium stearate, peppermint oil, sorbitol

Principal Display Panel

Sugar Free

Refreshing

Mint

38

Lozenges

Since Lofthouse's 1865

Fisherman's Friend

Menthol Cough Suppressant Lozenges

Cough Suppressant/Oral Anesthetic

Refreshing Mint Flavor

www.fishermansfriendusa.com

Sugar Free Refreshing Mint 38 Count

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
ASPARTAME (UNII: Z0H242BBR1)  
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:55711-066-0238 in 1 BOX; Type 0: Not a Combination Product08/10/201012/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/10/201012/31/2020
Labeler - Lofthouse of Fleetwood, Ltd. (212605588)
Establishment
NameAddressID/FEIBusiness Operations
Lofthouse of Fleetwood, Ltd.212605588manufacture(55711-066)

Revised: 6/2021
 
Lofthouse of Fleetwood, Ltd.