Label: ORIGINAL EXTRA STRONG ALL NATURAL FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT- menthol lozenge
- NDC Code(s): 55711-064-01
- 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 May 12, 2021
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each lozenge)
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.
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
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
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ORIGINAL EXTRA STRONG ALL NATURAL FISHERMANS FRIEND MENTHOL COUGH SUPPRESSANT
Product 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:55711-064-01 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(55711-064)