12 Hour Original Nasal Decongestant

Description

WinCo Foods Original Nasal Spray contains Oxymetazoline HCl at a concentration of 0.05%. This formulation is designed to provide fast and powerful relief from nasal congestion, offering up to 12 hours of symptom relief. The product is presented in a dosage form of a nasal spray, with a total volume of 1 fluid ounce (30 mL).

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 acts by shrinking swollen nasal membranes, thereby facilitating easier breathing.

There are no teratogenic or nonteratogenic effects associated with this drug as per the available data.

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, consultation with a healthcare professional is advised prior to use.

When administering the spray, the healthcare professional should instruct the patient to squeeze the bottle quickly and firmly. It is essential that the patient does not tilt their head backwards during the spraying process. After use, the nozzle should be wiped clean to maintain hygiene and prevent blockage.

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 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 without delay.

Healthcare professionals should advise 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 the potential adverse reactions associated with the use of this medication. In the event that symptoms persist, it is advised to stop use and consult a healthcare professional.

Before initiating treatment, patients are encouraged to seek medical advice if they have a history of heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland. These conditions may influence the safety and efficacy of the medication.

Monitoring for adverse reactions is essential, and patients should remain vigilant for any unexpected symptoms during the course of treatment.

Drug Interactions

There are no specific drug interactions identified for the product. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of 12 Hour Original Nasal Decongestant (nasal 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 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

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients 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 understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with its use during pregnancy.

Lactation

Lactating mothers should consult a health professional before using this medication. There is a potential for excretion in breast milk, and consideration of infant risk is advised when using this medication while breastfeeding.

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. Dosage adjustments should be guided by creatinine clearance levels, with specific recommendations for reduced doses provided for patients with varying degrees of renal impairment. Additionally, renal function tests should be performed prior to initiating therapy and periodically thereafter to ensure appropriate dosing and minimize the risk of adverse effects.

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 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 consider general principles of management for suspected cases of overdose.

It is essential to monitor patients closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Overall, due diligence in assessing the patient's condition and implementing appropriate interventions is crucial in managing any suspected overdose scenario effectively.

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

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to discontinue use and consult a healthcare provider if symptoms persist. Patients should be cautioned against exceeding the recommended dosage and should not use the product for more than three consecutive days. Emphasize that 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 crucial to inform patients that sharing this container with others may facilitate the spread of infection.

Healthcare providers should encourage patients to consult with a doctor prior to use 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 12 Hour Original Nasal Decongestant, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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