Sweet Comfort

Description

Sweet Comfort is an antitussive (cough suppressant) oil blend rub developed by Saje® Natural Wellness. This product is intended for external use only and is packaged in a 0.34 fl. oz. (10 ml) container.

Uses and Indications

This drug is indicated for use in adults and children aged 12 years and older for the application on the throat and chest. It should be applied in a thick layer and 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 inhalation of vapors.

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

There are no specific contraindications identified for this product. However, the following precautions should be observed to ensure safe use:

Heating the product is not recommended. It should not be heated, microwaved, or used near an open flame, as these actions may lead to hazardous conditions. Additionally, the product should not be added to hot water or any container where heating water is involved, as this may cause splattering and result in burns.

Furthermore, it is advised to avoid sun tanning or the use of tanning beds for 3-4 days following application to prevent adverse reactions.

Warnings and Precautions

For external use only; ingestion or nasal application is strictly prohibited. The product is flammable; therefore, it must be kept away from fire or flame to prevent any hazardous incidents.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if a cough persists for more than one week, recurs, or is accompanied by 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 should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and should not be ingested or placed in the nostrils. It is also 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, tends to recur, 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. Additionally, individuals with a cough accompanied by excessive phlegm (mucus) or those with a history of epilepsy should consult a healthcare provider prior to use.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Sweet Comfort (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 adults aged 12 years and older, the recommended application is to rub a thick layer on the throat and chest.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this 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 during 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, 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 intervention is recommended. 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 is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

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 additional nonclinical toxicology details provided. Furthermore, no specific information regarding animal pharmacology and toxicology has been documented.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 they should 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.

Patients should be cautioned against certain practices while using this product. Specifically, they should not heat, microwave, or use the product near an open flame. Additionally, they should avoid adding the product to hot water or any container where water is being heated, as this may cause splattering and result in burns. Furthermore, patients are advised to refrain from sun tanning or using tanning beds for 3-4 days following the use of the product.

Healthcare providers should also encourage patients to consult a doctor prior to use 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). Patients with a history of epilepsy should also seek medical advice before using the product.

Storage and Handling

The product is available in various packaging configurations, and the National Drug Code (NDC) numbers are provided for reference. It is essential to store the product in a tightly closed container to maintain its integrity. The recommended storage condition is at room temperature, away from heat sources.

Additionally, the organization supports recycling initiatives and encourages healthcare professionals to recycle the packaging where possible.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)