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| Product NDC Code | 55711-064 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Original extra strong all natural fishermans friend menthol cough suppressant |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||||
| Dosage Form | LOZENGE | ||||||||||
| RxCUI drug identifier | 199393, 1014609 |
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| Application Number | part341 | ||||||||||
| Labeler Name | Lofthouse of Fleetwood, Ltd. | ||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each lozenge) Menthol 10 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients capsicum, dextrin, eucalyptus oil, natural licorice, sugar, tragacanth
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves occasional minor sore throat cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants
Purpose
Information about the drug product’s indications for use.Purpose Cough suppressant/oral anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant Menthol CAPSICUM EUCALYPTUS OIL LICORICE RAW SUGAR TRAGACANTH MENTHOL MENTHOL light brown
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.FISHERMAN'S FRIEND ® ORIGINAL EXTRA STRONG Menthol Cough Suppressant Lozenges Cough Suppresant/Oral Anesthetic 20 Lozenges Manufactured by: Lofthouse of Fleetwood Ltd., Lancs, England Distributed by: Greenwood Brands, LLC. Buffalo-Niagara, NY 14225 [email protected] label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not use more than directed
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a health professional before use
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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. 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 When using this product do not use more than directed 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 If pregnant or breast-feeding , ask a health professional before use Keep out of reach of children.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API