Family Wellness Oxymetazoline

Description

Family Wellness Original Nasal Spray is a nasal decongestant formulated with 0.05% oxymetazoline hydrochloride. This product is designed to provide relief from nasal congestion for up to 12 hours. It is presented in a dosage form of a nasal mist, with a net weight of 1.0 fluid ounce (30 mL). The product is identified by the National Drug Code (NDC) 55319-985-28.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, sinusitis, and upper respiratory allergies. It functions by shrinking swollen nasal membranes, thereby facilitating easier breathing.

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

Dosage and Administration

For adults and 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.

For children under 6 years of age, it is advised to consult a physician prior to administration.

To properly administer the spray, the healthcare professional should instruct the patient to squeeze the bottle quickly and firmly. The patient should avoid tilting their head backward during the spraying process. After use, the nozzle should be wiped clean to maintain hygiene and prevent blockage.

Contraindications

The product should not be used in the following situations:

• Use is contraindicated for more than three consecutive days due to the risk of nasal congestion recurrence or worsening.

• The product should not be used in excess of the directed dosage.

• Use of this product by multiple individuals may lead to the spread of infection.

• If symptoms persist, discontinue use and consult a healthcare professional.

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 strictly adhered to in order to ensure safe usage. It is imperative that the product is not used in excess of the directed dosage. Additionally, the product should not be utilized for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Users may experience temporary discomfort, which can manifest as burning, stinging, sneezing, or an increase in nasal discharge. Furthermore, it is important 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 the Poison Control Center should be contacted without delay.

Healthcare professionals are advised to instruct patients to discontinue use and consult a physician if symptoms persist. This precaution is essential to ensure that any underlying conditions are appropriately addressed.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is important to consult a healthcare professional prior to use if there is a history of heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland.

While specific adverse reactions were not detailed in the provided information, the presence of these warnings indicates that patients with the aforementioned conditions may be at an increased risk for serious complications. Therefore, careful consideration and medical guidance are essential for individuals with these health concerns.

Monitoring for any unusual symptoms or reactions during treatment is advised, and patients should report any adverse effects to their healthcare provider promptly.

Drug Interactions

Patients with a history of heart disease, high blood pressure, diabetes, thyroid disease, or urinary difficulties due to an enlarged prostate gland are advised to consult a healthcare professional prior to using this medication. This precaution is essential to ensure safe use and to mitigate potential risks associated with these underlying conditions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Family Wellness Oxymetazoline (oxymetazoline). 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 to note that the total dosage should not 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

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 should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or its effects on breastfed infants.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients to ensure safe and effective dosing. Dosage adjustments should be guided by creatinine clearance levels, with particular attention given to those with severe renal impairment, as they may require special consideration in their treatment regimen.

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 standard protocols for managing suspected cases of drug overdose.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, the administration of activated charcoal may be considered if the patient presents within a suitable timeframe and is alert. In cases of severe toxicity, specific antidotes or advanced medical interventions may be required, depending on the substance involved.

Healthcare professionals should consult local poison control centers or toxicology experts for guidance on the management of overdose cases, ensuring that appropriate measures are taken to mitigate potential complications.

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 use of the compound in these contexts.

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 the use of the product. Additionally, it has been reported that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

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. 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.

Additionally, patients should be encouraged to consult a doctor before using the product if they have a history of 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 temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to retain the carton for future reference regarding the full labeling information. 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 Family Wellness Oxymetazoline, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)