SUGAR FREE REFRESHING MINT FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT- menthol lozenge

Sugar Free Refreshing Mint Fishermans Friend Menthol Cough Suppressant by

Drug Labeling and Warnings

Sugar Free Refreshing Mint 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)

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 DOCTOR

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

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

PREGNANCY OR BREAST FEEDING

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 information

Phenylketonurics: Contains Phenylalanine 0.45 mg Per Lozenge

Inactive Ingredients

aspartame, magnesium stearate, peppermint oil, sorbitol

Principal Display Panel

Sugar Free

Refreshing

Mint

Since Lofthouse's 1865

Fisherman's Friend

Menthol Cough Suppressant Lozenges

Cough Suppressant/Oral Anesthetic

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

Distributed by: Pez Candy Inc., 35 Prindle Hill Road, Orange, CT 06477

20 Lozenges

www.fishermansfriendusa.com

INGREDIENTS AND APPEARANCE

SUGAR FREE REFRESHING MINT FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55711-066
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PEPPERMINT OIL (UNII: AV092KU4JH)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	20mm
Flavor	MINT (Refreshing Mint)	Imprint Code	FF
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55711-066-01	20 in 1 PACKET; Type 0: Not a Combination Product	08/10/2010

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

Labeler - Lofthouse of Fleetwood, Ltd. (212605588)

Establishment
Name	Address	ID/FEI	Business Operations
Lofthouse of Fleetwood, Ltd.		212605588	manufacture(55711-066)