ORIGINAL EXTRA STRONG ALL NATURAL 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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Drug Facts

Active ingredient (in each lozenge)

Menthol 10 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

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. If sore throat is severe or persists more than 2 days accompanied by headache, nausea, and vomiting, contact a doctor right away. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

Keep out of reach of children.

When using this product do not use more than directed

If pregnant or breast-feeding, ask a health professional before use

Directions


  • adults and children 2  to under 12 years of age: allow lozenge to dissolve slowly in the mouth
  • may be repeated every hour as needed for cough, or every 2 hours as needed for sore throat, or as directed by a doctor
  • children under 2 years of age: consult a doctor

Inactive ingredients

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

Principal Display Panel

Fisherman's Friend

Menthol Cough Suppressant Lozenges

Original

Extra

Strong

Distributed by: Pez Candy Inc.,

35 Prindle Hill Road,

Orange, CT 06477

Made in England

35 Lozenges

Original Extra Strong 35 Count

ORIGINAL EXTRA STRONG ALL NATURAL FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55711-064
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
Inactive Ingredients
Ingredient NameStrength
CAPSICUM (UNII: 00UK7646FG)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
LICORICE (UNII: 61ZBX54883)  
RAW SUGAR (UNII: 8M707QY5GH)  
TRAGACANTH (UNII: 2944357O2O)  
Product Characteristics
Colorbrown (light brown) Scoreno score
ShapeOVALSize20mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55711-064-0635 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(55711-064)

Revised: 4/2021
 
Lofthouse of Fleetwood, Ltd.