Sunmark Nasal

Description

Oxymetazoline hydrochloride 0.05% is a nasal decongestant formulated for the relief of nasal congestion associated with colds and allergies. This product is classified as Maximum Strength and is designed to provide fast and powerful relief for up to 12 hours. It is presented in a 1 fluid ounce (30 mL) dosage form and is gluten-free.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, and upper respiratory allergies. It also provides temporary relief from sinus congestion and pressure. Additionally, this drug acts to shrink swollen nasal membranes, facilitating easier breathing.

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

Dosage and Administration

Adults and children aged 6 to under 12 years of age, when administered under adult supervision, may receive 2 or 3 sprays in each nostril. Dosing should not occur more frequently than every 10 to 12 hours, and it is important not to exceed 2 doses within a 24-hour period. For children under 6 years of age, consultation with a physician is recommended prior to use.

For proper administration, the following steps should be followed: Firmly push down on the cap and turn it counterclockwise to open. To deliver the spray, squeeze the bottle quickly and firmly while ensuring that the head is not tilted backward during the application. After use, the nozzle should be wiped clean, and the cap should be securely replaced.

Contraindications

Use is contraindicated in patients who exceed the directed dosage or utilize the product for more than three consecutive days. Frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product, particularly in patients with specific underlying health conditions. Prior to use, it is imperative to consult a physician if the patient has a history of heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland.

It is essential to adhere strictly to the recommended dosage guidelines. Patients should not exceed the directed use and should limit the duration of use to no more than three days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Users may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is important to note that sharing this product among multiple users may facilitate the spread of infection.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients should be advised to discontinue use and consult a healthcare provider if symptoms persist.

Side Effects

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

If symptoms persist, patients are advised to discontinue use and consult a healthcare professional for further evaluation and guidance.

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 Sunmark Nasal (oxymetazoline hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. It is important not to exceed 2 doses within a 24-hour period. For children under 6 years of age, consultation with a healthcare professional is advised prior to use.

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. It is advisable to monitor these patients closely for any 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. 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 may use this medication to temporarily relieve nasal congestion associated with common cold, hay fever, and upper respiratory allergies, as well as to alleviate sinus congestion and pressure. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, healthcare professionals should weigh the potential benefits against any risks when considering this treatment for lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 event of an overdosage, immediate medical assistance is crucial. If the product 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. It is recommended that healthcare providers assess the patient's condition and consider the necessity for supportive care or specific treatment protocols based on the severity of symptoms presented.

Nonclinical Toxicology

No teratogenic effects were reported in the studies conducted. Additionally, there was no increase in fetal malformations observed, indicating a lack of non-teratogenic effects.

Information regarding nonclinical toxicology and animal pharmacology and toxicology was not provided in the insert.

Postmarketing Experience

Temporary discomfort, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge, has been reported in postmarketing experience. Additionally, frequent or prolonged use of the product may lead to a recurrence or worsening of nasal congestion. These events have been documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to stop using the product and consult a doctor if symptoms persist. It is important to emphasize that when using this product, patients must not exceed the directed dosage and should not use it for more than three days. 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. Additionally, inform patients that the use of this container by more than one person may increase the risk of spreading infection.

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

Storage and Handling

The product is supplied in packaging that includes the relevant NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F). It is important to retain the carton for future reference regarding the full labeling and any additional information.

Additional Clinical Information

The medication is administered via the nasal route. For adults and children aged 6 to under 12 years, it is recommended to use 2 or 3 sprays in each nostril, not more frequently than every 10 to 12 hours, with a maximum of 2 doses within a 24-hour period. For children under 6 years of age, consultation with a doctor is advised prior to use.

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

Drug Information (PDF)

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

View product document (PDF)