Fortify

Description

Fortify Antitussive (Cough Suppressant) Oil Blend Rub is a topical formulation provided in a 30 ml (1 fl. oz.) container. This product is manufactured by Saje® Natural Wellness and is designed for use as a cough suppressant. The blend consists of natural ingredients formulated to provide relief from cough symptoms when applied to the skin.

Uses and Indications

This drug is indicated for the topical application in adults and children aged 12 years and older. It is to be applied in a thick layer to the throat and chest. For enhanced efficacy, the area may be covered with a warm, dry cloth if desired. It is recommended that clothing around the throat and chest be loose to facilitate the release of vapors to the nose and mouth.

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

Dosage and Administration

The recommended dosage for the medication is up to three times daily, or as directed by a healthcare professional. For children under 12 years of age, it is advised to consult a doctor prior to administration to determine the appropriate dosage and ensure safety.

Contraindications

Use of this product is contraindicated in patients with a history of epilepsy due to the potential for exacerbating seizures. Additionally, it should not be used in individuals with high blood pressure, as it may pose further cardiovascular risks.

The product should not be subjected to heating, microwaving, or exposure to an open flame. It is also contraindicated to add the product to hot water or any container where water is being heated, as this may lead to splattering and result in burns.

Warnings and Precautions

For external use only; this product is not intended for oral ingestion or nasal application. It is important to note that the product is flammable; therefore, it should be kept away from fire or flame to prevent any hazardous incidents.

In the event of accidental ingestion, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center or seek emergency medical help without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if a cough persists for more than one week, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation and management.

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that this product is for external use only and should not be ingested or placed in the nostrils. Additionally, the product is flammable; therefore, it should be kept away from fire or flame.

In clinical practice, patients are advised to stop using the product and consult a healthcare professional if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache. A persistent cough may indicate a serious underlying condition that requires medical evaluation.

Before using this product, patients should seek medical advice if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). These conditions may necessitate a different therapeutic approach.

Drug Interactions

The use of this medication is contraindicated in patients with a history of epilepsy due to the potential for exacerbating seizures. Additionally, it should not be administered to individuals with high blood pressure, as it may pose significant health risks.

There are no specific interactions identified between this medication and laboratory tests, indicating that it does not interfere with the results of standard diagnostic assessments.

Packaging & NDC

Below are the non-prescription pack sizes of Fortify (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the recommended application is to rub a thick layer on the throat and chest, up to three times daily or as directed by a healthcare provider.

Geriatric Use

There is no specific information regarding the use of Fortify Antitussive (Cough Suppressant) Oil Blend Rub in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this product to elderly patients. It is advisable to monitor for any potential adverse effects or changes in efficacy, as older adults may have altered pharmacokinetics and pharmacodynamics. Additionally, clinicians should consider individual patient factors, including comorbidities and concurrent medications, when determining the appropriateness of this treatment in the geriatric population.

Pregnancy

Pregnant patients and those who are breastfeeding should not use this product. The potential risks associated with the use of this product during pregnancy or lactation have not been established, and its safety in these populations has not been evaluated. Therefore, healthcare professionals are advised to consider alternative treatments for women who are pregnant or nursing.

Lactation

Lactating mothers are advised against the use of this product while breastfeeding. There is no available data on the excretion of the product in human milk or its effects on breastfed infants. Therefore, caution is warranted, and alternative treatments should be considered for lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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 available information.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and consider general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be prioritized.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, as these could indicate an adverse response to excessive dosing.

Management Procedures Management of overdosage should be tailored to the individual patient, taking into account their medical history and the context of the overdose. In cases where the substance involved is known, specific antidotes or interventions may be applicable. Consultation with a poison control center or toxicology expert is recommended for guidance on the most effective management strategies.

In summary, due to the lack of specific overdosage information, healthcare professionals must rely on their clinical judgment and established protocols for managing potential overdosage scenarios.

Nonclinical Toxicology

If pregnant or breastfeeding, the use of this product is contraindicated due to potential teratogenic effects. There are no specific non-teratogenic effects or detailed nonclinical toxicology data available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that this product should not be used by individuals with epilepsy or those who have high blood pressure.

Patients should be instructed to discontinue use and consult a doctor if their cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

When discussing the use of this product, healthcare providers should emphasize that it should not be heated, microwaved, or used near an open flame. Patients should also be cautioned against adding the product to hot water or any container where water is being heated, as this may cause splattering and result in burns.

Additionally, healthcare providers should recommend that patients consult a doctor before using the product if they have a persistent or chronic cough associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a container that should be closed tightly after use. It is recommended to store the product at room temperature, ensuring it is kept away from heat sources. Additionally, recycling of the container is encouraged where possible.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Fortify, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)