Nasal

Description

This formulation contains oxymetazoline hydrochloride as the active ingredient, providing maximum strength nasal decongestant properties. It is designed to deliver fast and powerful relief from severe sinus congestion and pressure. The product features an ultra-fine mist delivery system, ensuring effective application. Each bottle contains 1 fluid ounce (30 mL) of the solution, which offers up to 12 hours of relief. Additionally, the formulation includes menthol, enhancing the overall efficacy compared to the active ingredient found in Vicks® Sinex® Severe.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with colds, hay fever, or other upper respiratory allergies. Additionally, it provides temporary relief from sinus congestion and pressure.

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

Dosage and Administration

The medication should be shaken well before use. For administration, the white tabs should be held while firmly squeezing the grooved area of the cap and turning it counterclockwise. Prior to the initial use, the pump must be primed by firmly depressing its rim several times.

To administer the medication, the container should be held with the thumb at the base and the nozzle positioned between the first and second fingers. The nozzle should be inserted into the nostril without tilting the head. The rim should be fully depressed with a firm, even stroke while inhaling deeply.

For adults and children aged 6 years and older, the recommended dosage is 2 or 3 sprays in each nostril, not to be administered more frequently than every 10 to 12 hours. The total dosage should not exceed 2 doses within a 24-hour period.

For children aged 2 to under 6 years, it is advised to consult a doctor before use. The medication is not recommended for children under 2 years of age. After use, the cap should be secured to maintain the integrity of the product.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage or utilize it for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. It is essential to adhere strictly to the directions provided.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product, particularly in patients with specific underlying health conditions. It is imperative to consult a physician prior to use in individuals with a history of heart disease, thyroid disease, diabetes, high blood pressure, or urinary difficulties due to an enlarged prostate gland.

When utilizing this product, adherence to the recommended dosage is crucial. Exceeding the advised dosage or using the product for more than three consecutive days is not recommended, as this may lead to a recurrence or exacerbation of nasal congestion. The product should be used strictly as directed to mitigate risks. Users may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is important to note that sharing this container with others may facilitate the spread of infection.

In the event that symptoms persist despite use, it is essential to discontinue use and seek medical advice. Should the product be ingested, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is advised.

Side Effects

Patients using this product may experience temporary discomfort, which can include symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. These reactions are generally mild and transient.

It is important for patients to stop using the product and consult a healthcare professional if symptoms persist. Additionally, patients should seek medical advice before using this product if they have a history of heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

Patients are advised not to exceed the recommended dosage and to refrain from using the product for more than three days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Furthermore, sharing this product among multiple users may increase the risk of spreading infections.

In the event of accidental ingestion, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 years and older may receive 2 or 3 sprays in each nostril, with administration not to exceed every 10 to 12 hours. The maximum dosage should not exceed 2 doses within a 24-hour period.

For children aged 2 to under 6 years, it is advised to consult a healthcare professional before use. The product is contraindicated in 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 potential adverse effects or changes in efficacy, 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate management strategies should be implemented based on clinical presentation and the substance's pharmacological profile.

Healthcare providers are encouraged to monitor the patient closely and provide supportive care as necessary. It is imperative to follow established protocols for the management of overdosage, which may include decontamination, symptomatic treatment, and specific antidotes if applicable.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Temporary discomfort may occur, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that temporary discomfort, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge, may occur following use. Additionally, it has been reported that the use of this container by more than one person may facilitate the spread of infection.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. Patients should be informed to discontinue use and consult a doctor if symptoms persist.

When using this product, it is essential to emphasize the importance of adhering to the recommended dosage and not exceeding it. Patients should be instructed not to use the product for more than three days and to follow the directions provided. They should be made aware that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patients may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. It is important to inform them that sharing this container with others may increase the risk of spreading infection.

Additionally, healthcare providers should encourage patients to consult a doctor before using the product if they have any of the following conditions: heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

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 at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)