SUGAR FREE HONEY-LEMON 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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Honey Lemon

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.

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

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 finalpart34105/02/2019
Labeler - Lofthouse of Fleetwood, Ltd. (212605588)
Establishment
NameAddressID/FEIBusiness Operations
Lofthouse of Fleetwood, Ltd.212605588manufacture(55711-071)

Revised: 5/2021
Document Id: c24b12b7-b4a4-1a4c-e053-2a95a90a05d3
Set id: 87ebb4d9-78d7-1c87-e053-2a95a90adb7d
Version: 4
Effective Time: 20210514
 
Lofthouse of Fleetwood, Ltd.