Severe Sinus Relief Mist

Description

Walgreens Severe Sinus Relief Mist is a nasal spray formulation containing oxymetazoline hydrochloride at a concentration of 0.05%. This product is designed for 12-hour relief of nasal congestion. It is packaged in a net weight of 0.5 fluid ounces (15 mL).

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 by shrinking swollen membranes, facilitating easier breathing.

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

Dosage and Administration

Before the initial use, the protective cap must be removed from the tip, and the pump should be primed by firmly depressing it several times.

For administration, the bottle 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 and even stroke while the patient sniffs deeply.

After each use, the nozzle should be wiped clean to maintain hygiene.

For adults and children aged 6 to under 12 years (with adult supervision), the recommended dosage is 2 to 3 sprays in each nostril, not to exceed 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 doctor is advised prior to use.

Contraindications

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

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

General precautions must be observed to ensure safe usage. It is imperative that the product is not used in excess of the directed dosage. Prolonged use beyond three days is discouraged, as it may lead to a recurrence or worsening of nasal congestion. Users should be informed that temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge, may occur during use. Additionally, it is critical to note that sharing this container among multiple individuals may facilitate the spread of infection.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should instruct patients to discontinue use and consult a physician if symptoms persist, ensuring that appropriate follow-up care is provided.

Side Effects

Patients should be aware of certain warnings associated with the use of this medication. It is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use. Additionally, patients are instructed to discontinue use and seek medical advice if symptoms persist.

Before initiating treatment, it is important for patients to consult a doctor if they have a history of heart disease, high blood pressure, diabetes, thyroid disease, or if they experience trouble urinating due to an enlarged prostate gland. These considerations are crucial to ensure the safe and effective use of the medication.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with 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 Severe Sinus Relief Mist (oxymetazoline spray). 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 than every 10 to 12 hours. It is important to note that the total dosage should not exceed 2 doses within a 24-hour period, and administration should occur under adult supervision.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, careful consideration and professional guidance are recommended to ensure the safety of both the mother and the nursing infant.

Renal Impairment

Patients with renal impairment may require dosage adjustments based on their creatinine clearance levels. It is essential for healthcare professionals to monitor renal function regularly in these patients. Special consideration should be given to those with severe renal impairment, as they may have different therapeutic needs. Renal function tests should be conducted prior to initiating therapy and periodically thereafter to ensure appropriate dosing and to mitigate potential risks associated with reduced kidney function.

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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or unexpected reactions.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage data, it is recommended that healthcare professionals refer to established clinical guidelines and consult with poison control centers for further management strategies. Continuous evaluation of the patient's condition is crucial to ensure appropriate care and intervention.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Patients should be advised to seek medical help or contact a Poison Control Center immediately if the product is swallowed. It is important to instruct patients to stop using the product and consult a doctor if symptoms persist. They should be cautioned against using the product more than directed and not to exceed a usage period of three days, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patients may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. It is essential to inform patients that the use of this container by more than one person may facilitate the spread of infection.

Healthcare providers should encourage patients to consult a doctor before using the 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 specific NDC numbers, which should be referenced for identification. It is essential to store the product at a controlled temperature between 20° and 25°C (68° to 77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to retain the carton for future reference, as it contains important information regarding the full labeling of the product. Proper handling and storage conditions are crucial to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)