Berkley and Jensen Nasal

Description

Oxymetazoline HCl 0.05% is a nasal decongestant formulated to provide fast and powerful relief from severe congestion associated with colds and allergies. This product is designed as a pump mist nasal spray, ensuring that it does not drip from the nose or down the throat. Each package contains two 1 fl oz (30 mL) bottles, totaling 2 fl oz (60 mL) of solution. The formulation includes maximum strength plus menthol, offering up to 12 hours of relief from nasal congestion.

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 medication acts to shrink swollen nasal membranes, facilitating easier breathing.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults and children aged 6 to under 12 years, under adult supervision, may receive 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. The maximum allowable dosage is 2 doses within a 24-hour period. For children under 6 years of age, consultation with a physician is recommended prior to use.

To prepare for administration, the product should be shaken well. The user should hold the white tabs, firmly squeeze the grooved area of the cap, and turn it counterclockwise. Prior to the initial use, the metered pump must be primed by firmly depressing the pump several times. For application, 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, even stroke while the user sniffs deeply. After use, the nozzle should be wiped clean, and the cap should be securely replaced.

Contraindications

Use is contraindicated in patients who exceed the recommended dosage or duration of use. Specifically, the product should not be used for more than three days, as frequent or 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 medication.

Patients should be advised to consult a physician prior to use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. These conditions may increase the risk of adverse effects or complications.

It is crucial to adhere strictly to the recommended dosage. 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. Additionally, temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur during use.

Healthcare providers should also inform patients that sharing this medication with others may pose a risk of spreading infection, as the container is intended for single-person use.

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 are advised to discontinue use and consult a physician if symptoms persist, as this may indicate a need for further evaluation or alternative treatment options.

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

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

Pediatric Use

Pediatric patients under 6 years of age should consult a healthcare professional before use. For children aged 6 to under 12 years, the recommended dosage is 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. Adult supervision is advised for this age group during administration.

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. 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 unknown risks when considering this treatment for lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed 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 medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions 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, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 instructed to discontinue use and consult a doctor if symptoms persist.

When using this product, it is essential to inform patients that they should not exceed the recommended dosage and should not use it for more than three days. Emphasize that the product should only be used as directed, as 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, healthcare providers should caution patients against sharing the container with others, as this may facilitate the spread of infection.

Before initiating use, patients should be encouraged to consult with their healthcare provider if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, 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 retained for future reference regarding the complete labeling information. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to ensure its stability and efficacy. Additionally, the carton should be kept for future reference to access the full labeling details.

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 Berkley and Jensen Nasal, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)