Drug Facts

Active ingredient (in each lozenge)

Menthol 10 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 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

capsicum, dextrin, eucalyptus oil, natural licorice, sugar, tragacanth

FISHERMAN'S FRIEND ®

ORIGINAL EXTRA STRONG

Menthol Cough Suppressant Lozenges

Cough Suppresant/Oral Anesthetic

20 Lozenges

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

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

ffinfo@greenwoodg.com

label

ORIGINAL EXTRA STRONG ALL NATURAL FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55711-064
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg

Ingredient Name	Strength
Inactive Ingredients
CAPSICUM (UNII: 00UK7646FG)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LICORICE (UNII: 61ZBX54883)
RAW SUGAR (UNII: 8M707QY5GH)
TRAGACANTH (UNII: 2944357O2O)

Product Characteristics
Color	brown (light brown)	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55711-064-01	20 in 1 PACKET; Type 0: Not a Combination Product	08/10/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/10/2010

Labeler - Lofthouse of Fleetwood, Ltd. (212605588)

Name	Address	ID/FEI	Business Operations
Establishment
Lofthouse of Fleetwood, Ltd.		212605588	manufacture(55711-064)