Nosk Ex Sleep

Description

The product is a combination of diphenhydramine hydrochloride and acetaminophen, formulated as round, pink, film-coated tablets. Each tablet contains 25 mg of diphenhydramine hydrochloride and 500 mg of acetaminophen. Inactive ingredients include microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, red iron oxide, and yellow iron oxide. The SPL Code for this product is 34089-3.

Uses and Indications

This drug is indicated for application to the back of the neck, cervical vertebrae, and shoulder areas to promote wakefulness and refreshment.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals are advised to administer an adequate amount of this product as part of the treatment regimen. The specific dosage may vary based on individual patient needs and clinical circumstances. It is essential to assess the patient's condition and adjust the dosage accordingly to ensure optimal therapeutic outcomes.

For administration, the product should be taken as directed, ensuring that the method of intake aligns with the recommended guidelines for use. Regular monitoring of the patient's response to the treatment is recommended to facilitate any necessary adjustments in dosage.

Contraindications

There are no contraindications listed for this product. It is important to evaluate individual patient circumstances and consult relevant clinical guidelines when considering its use.

Warnings and Precautions

Caution is advised as this product is intended for external use only. It should not be applied to the eyes, wounds, broken skin, or deep puncture wounds. The product is suitable for individuals aged 7 years and older.

Healthcare professionals should instruct patients to avoid contact with the eyes during application. In the event of a rash, it is imperative to discontinue use and consult a physician. Additionally, patients should be advised to keep the product out of reach of children to prevent accidental ingestion or misuse.

If patients experience any adverse reactions such as rash, swelling, or itchiness, they are recommended to cease application immediately and seek advice from a dermatologist.

Storage conditions are also critical; the product should not be exposed to extreme temperatures or direct sunlight to maintain its efficacy and safety.

Side Effects

Patients using this product should be aware of several important cautions regarding its application and potential adverse reactions. This product is intended for external use only and should not be applied to the eyes, wounds, broken skin, or deep puncture wounds. It is recommended for individuals aged 7 years and older.

During use, patients must avoid contact with the eyes. In the event that a rash occurs, it is advised to discontinue use and consult a healthcare professional. Additionally, if patients experience symptoms such as rash, swelling, or itchiness, they should stop applying the product and seek immediate advice from a dermatologist.

To ensure safety, this product should be kept out of reach of children and should not be stored in extreme temperatures or exposed to direct sunlight. These precautions are essential to minimize the risk of adverse reactions and ensure the safe use of the product.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 7 years and older may be considered for treatment with this medication. Safety and efficacy have not been established in children younger than 7 years. Therefore, caution is advised when prescribing to this population, and appropriate dosing should be determined based on the patient's age and clinical condition.

Geriatric Use

Elderly patients should be aware that this product is intended for external use only and should not be applied to the eyes, wounds, broken skin, or deep puncture wounds. The product is approved for use in individuals aged 7 years and older, which includes the geriatric population.

Healthcare providers should advise elderly patients to discontinue use and consult a dermatologist immediately if they experience any adverse reactions, such as rash, swelling, or itchiness. Close monitoring for these symptoms is recommended, as the elderly may be more susceptible to skin reactions.

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding use during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 information necessitates careful clinical judgment and monitoring of these patients.

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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with improper access to the medication, ensuring that patients understand the necessity of safeguarding it in their home environment.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product within the recommended temperature range to maintain its efficacy. The product should not be exposed to high or low temperatures, nor should it be left in direct sunlight. Proper storage conditions are crucial to ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)