Label: ORIGINAL EXTRA STRONG ALL NATURAL FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT- menthol lozenge
- NDC Code(s): 55711-064-05
- Packager: Lofthouse of Fleetwood, Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 25, 2021
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- Official Label (Printer Friendly)
- Active ingredient (in each lozenge)
- Purpose
- Uses
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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 of doctor promptly.
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- Directions
- Inactive ingredients
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Principal Display Panel
Original
Extra
Strong
Trial Size
Since Lofthouse's 1865
Fisherman's Friend
Menthol Cough Suppressant Lozenges
Cough Suppressant/Oral Anesthetic
No Artificial Flavors or Ingredients
2 Lozenges
Manufactured by:
Lofthouse of Fleetwood Ltd., Lancs., England
Distributed by: Pez Candy Inc.
35 Prindle Hill Road, Orange, CT 06477
www.fishermansfriend.com
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INGREDIENTS AND APPEARANCE
ORIGINAL EXTRA STRONG ALL NATURAL FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55711-064 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55711-064-05 2 in 1 PACKET; Type 0: Not a Combination Product 09/08/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/08/2010 Labeler - Lofthouse of Fleetwood, Ltd. (212605588) Establishment Name Address ID/FEI Business Operations Lofthouse of Fleetwood, Ltd. 212605588 manufacture(55711-064)