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

Sugar Free Honey-Lemon Fishermans Friend Menthol Cough Suppressant by

Drug Labeling and Warnings

Sugar Free Honey-Lemon Fishermans Friend Menthol Cough Suppressant by is a Otc medication manufactured, distributed, or labeled by Lofthouse of Fleetwood, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each lozenge) - Purpose

Active ingredient (in each lozenge) - Purpose

Menthol 5.52 mg 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

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.

Manufactured By & Distributed By

SUGAR FREE HONEY-LEMON MENTHOL COUGH SUPPRESSANT LOZENGES

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

Made in England

DRUG FACTS LABEL

Drug Fact Label for Sugar Free Honey-Lemon Fishermans Friend

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55711-071
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.52 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
SORBITOL (UNII: 506T60A25R)
ACESULFAME (UNII: MA3UYZ6K1H)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	white (White lozenge with honey-colored spots)	Score	score with uneven pieces
Shape	OVAL (Oval lozenge 22mm x 13mm)	Size	20mm
Flavor	LEMON (Honey-Lemon Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55711-071-01	2 in 1 PACKET; Type 0: Not a Combination Product	05/02/2019
2	NDC: 55711-071-03	40 in 1 BAG	05/02/2019
2	NDC: 55711-071-02	20 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 55711-071-02	20 in 1 PACKET; Type 0: Not a Combination Product	05/02/2019
4	NDC: 55711-071-04	40 in 1 BOX	05/02/2019
4	NDC: 55711-071-02	20 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/02/2019

Labeler - Lofthouse of Fleetwood, Ltd. (212605588)

Establishment
Name	Address	ID/FEI	Business Operations
Lofthouse of Fleetwood, Ltd.		212605588	manufacture(55711-071)