Otc - Active Ingredient
Active ingredient (in each lozenge)
Menthol 5 mg
Fishermans Friend Lozenge
FDA Label NDC 55711-101
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 for the product Fishermans Friend (NDC 55711-101). 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 otc - active ingredient, otc - purpose, indications & usage, 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
Otc - Purpose
Purpose
Oral anesthetic
Indications & Usage
Uses For the temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.
Warnings
Warnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomitting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.
Otc - Ask Doctor
Ask a doctor before use if • you have a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days • a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting.
Otc - When Using
When using this product do not use more than directed.
Otc - Stop Use
Stop use and ask a doctor if • sore throat lasts more than 2 days or occurs with fever, rash, or headache that lasts • sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens
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.
Dosage & Administration
Directions • adults and children 2 years of age and older: allow product to dissolve slowly in the mouth. • may be repeated every 2 hours as needed or as directed by a dentist or doctor • children under 2 years of age: consult a dentist or doctor.
Orange Ginger
Inactive ingredients Acesulfame K, artificial orange ginger flavor, megnesium stearate, sorbitol, sucralose, FD&C Yellow No. 6.
SUGAR FREE
EST. 1865
FISHERMAN'S FRIEND ®
ORANGE GINGER
ARTIFICIAL FLAVOR
Menthol - Oral Anesthetic
20 LOZENGES
Gluten Free - Contains no ingredient made from a gluten - containing grain (wheat, barley or rye)
Mixed Berry
Inactive ingredients Acesulfame K, artificial mixed berries flavor, magnesium stearate, sorbitol, sucralose.
SUGAR FREE
EST. 1865
FISHERMAN'S FRIEND ®
MIXED BERRY
ARTIFICIAL FLAVOR
Menthol - Oral Anesthetic
20 LOZENGES
Gluten Free - Contains no ingredient made from a gluten - containing grain (wheat, barley or rye)
Other
Manufactured by: Lofthouse of Fleetwood Ltd., Lancs, England FY7 7LP
Distributed by: Greenwood Brands, LLC. Buffalo - Niagara, NY 14225
[email protected] MADE IN ENGLAND
* Please review the disclaimer below.
