Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of occasional minor sore throat. It is also indicated for the alleviation of cough associated with minor throat and bronchial irritation that occurs with the common cold or as a result of inhaled irritants.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 2 years and older are instructed to allow one lozenge to dissolve slowly in the mouth. This process may be repeated every 2 hours as needed or as directed by a healthcare professional. For children under 2 years of age, it is recommended to consult a doctor prior to administration.

Contraindications

There are no specific contraindications identified for this product. However, it is advised that the product should not be used in excess of the directed dosage.

Warnings and Precautions

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. Healthcare professionals should advise patients to seek medical attention immediately under these circumstances. It is also critical to note that the product should not be used for more than 2 days or administered to children under 2 years of age unless specifically directed by a physician.

Before recommending this product, healthcare providers should inquire about the patient's medical history, particularly if the patient has a cough associated with excessive phlegm (mucus) or a persistent or chronic cough due to conditions such as smoking, asthma, or emphysema. In such cases, consultation with a healthcare professional is advised prior to use.

Patients should be instructed to discontinue use and contact their healthcare provider if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may signify a more serious underlying condition. Additionally, if a sore throat is severe, lasts longer than 2 days, or is followed by fever, headache, rash, swelling, nausea, or vomiting, patients should stop taking the product and seek medical advice.

No specific laboratory tests are recommended for monitoring the use of this product.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting. Such symptoms may indicate a serious condition, and patients are advised to seek medical attention immediately.

Common adverse reactions warranting caution include a cough that persists for more than 7 days, recurs, or occurs alongside fever, rash, or headache lasting beyond the initial episode. These symptoms may also suggest the presence of a serious underlying condition.

Patients should discontinue use and consult a healthcare professional if they experience a sore throat that is severe, lasts more than 2 days, or is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting.

Additionally, patients are advised to consult a doctor before using this medication if they have a cough that produces excessive phlegm (mucus) or if they have a persistent or chronic cough associated with conditions such as smoking, asthma, or emphysema.

It is important to note that this medication should not be used for more than 2 days or administered to children under 2 years of age unless directed by a healthcare professional.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication unless directed by a healthcare professional. For children aged 2 years and older, the recommended dosage is one lozenge to be dissolved slowly in the mouth, with the option to repeat every 2 hours as needed or as directed by a doctor. It is important for caregivers to consult a physician before administering this medication to children under 2 years of age.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be instructed to stop using the product and consult a doctor if their cough lasts more than 7 days, returns, or is accompanied by fever, rash, or headache, as these symptoms may indicate a serious condition. Additionally, if a patient experiences a sore throat that is severe, lasts more than 2 days, or is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, they should seek medical advice.

It is important to emphasize to patients that they should not exceed the recommended dosage when using this product. Furthermore, healthcare providers should encourage patients to consult a doctor before using the product if they have a cough that produces excessive phlegm (mucus) or if they have a persistent or chronic cough associated with conditions such as smoking, asthma, or emphysema.

Storage and Handling

The product is supplied in lozenge form, with specific handling and storage requirements to ensure its efficacy. It should be stored at room temperature, away from moisture. To maintain product integrity, it is essential to keep the lozenges in their original packaging until they are ready for use. Any unused lozenges must be discarded after the expiration date to ensure safety and effectiveness.

Additional Clinical Information

The medication is administered orally. For adults and children aged 2 years and older, the recommended dosage is to allow one lozenge to dissolve slowly in the mouth, with the option to repeat every 2 hours as needed or as directed by a healthcare professional. For children under 2 years of age, it is advised to consult a doctor before administration.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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