Active Ingredient (In Each Lozenge)
Menthol 10 mg
Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant Lozenge
FDA Label NDC 55711-064
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lofthouse Of Fleetwood, Ltd. for the product Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant (NDC 55711-064). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each lozenge), purpose, uses, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - 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
Otc - When Using
When using this product
do not use more than directed
Otc - 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Otc - 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
capsicum, dextrin, eucalyptus oil, natural licorice, sugar, tragacanth
Other
FISHERMAN'S FRIEND ®
ORIGINAL EXTRA STRONG
Menthol Cough Suppressant Lozenges
Cough Suppresant/Oral Anesthetic
Manufactured by: Lofthouse of Fleetwood Ltd., Lancs, England
Distributed by: Greenwood Brands, LLC. Buffalo-Niagara, NY 14225
* Please review the disclaimer below.
