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12 Hour Nasal Decongestant Extra Moisturizing

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Active ingredient
Oxymetazoline Hydrochloride 50 mg/100 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Liquid
Route
Nasal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
November 21, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride 50 mg/100 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Liquid
Route
Nasal
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
November 21, 2024
Manufacturer
WinCo Foods LLC
Registration number
M012
NDC root
67091-377
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Oxymetazoline HCL 0.05% is an extra moisturizing nasal spray designed to provide fast and powerful relief from nasal congestion. It works by temporarily shrinking swollen membranes in your nasal passages, helping you breathe more freely. This medication is effective for relieving congestion caused by common colds, hay fever, sinusitis, and upper respiratory allergies, offering up to 12 hours of relief in a convenient 1 FL OZ (30ml) bottle.

Uses

If you're dealing with nasal congestion from a common cold, hay fever, sinusitis, or upper respiratory allergies, this medication can help. It works by temporarily relieving your nasal congestion, allowing you to breathe more freely.

By shrinking the swollen membranes in your nasal passages, it makes it easier for you to get the air you need. This can be especially helpful when you're feeling under the weather or suffering from allergies.

Dosage and Administration

When using this medication, adults and children aged 6 to under 12 years should spray 2 or 3 times in each nostril. You can do this every 10 to 12 hours, but make sure not to exceed 2 doses in a 24-hour period. It's important to have adult supervision for children in this age group.

If your child is under 6 years old, you should consult a doctor before using this medication. To apply the spray, squeeze the bottle quickly and firmly, and remember not to tilt your head backward while spraying. After each use, be sure to wipe the nozzle clean to keep it functioning properly.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should not use it for more than three days, as prolonged use can lead to worsening nasal congestion. Always follow the directions provided and avoid using more than the recommended amount. This will help prevent any potential misuse or complications. If you have any concerns or questions about your treatment, please consult your healthcare provider.

Side Effects

If you experience any persistent symptoms while using this medication, it's important to stop using it and consult your doctor. Before starting this medication, you should also talk to your doctor if you have any of the following conditions: heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland. Your health and safety are the top priority, so make sure to seek professional advice if you have any concerns.

Warnings and Precautions

If you accidentally swallow this medication, it's important to seek medical help immediately or contact a Poison Control Center. Your safety is a priority, so don’t hesitate to get assistance.

If you notice that your symptoms continue or do not improve, please stop taking the medication and reach out to your doctor for further guidance. It's always best to consult with a healthcare professional if you have any concerns about your treatment.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult with a healthcare professional before using this medication. They can provide guidance tailored to your specific situation and help you understand any potential risks. Always prioritize your health and the health of your baby by seeking expert advice.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with a health professional before using any medication. They can provide guidance on the safety and potential effects on your milk production and your baby. Always prioritize your health and your baby's well-being by seeking expert advice.

Pediatric Use

When using this medication for children aged 6 to under 12 years, you can administer 2 or 3 sprays in each nostril, but only with adult supervision. It's important to space these doses out, allowing at least 10 to 12 hours between them, and never give more than 2 doses in a 24-hour period.

For children under 6 years old, it's essential to consult a doctor before use. This ensures their safety and helps determine the best course of action for their specific needs.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is particularly true if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste). Regular monitoring of your kidney function tests is essential to ensure your treatment remains safe and effective.

For those with significant renal impairment, special monitoring is advised to help manage your health effectively. Always consult with your healthcare provider about the best approach for your specific situation.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your safety and well-being are the top priority, and clear communication is key to achieving the best outcomes.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° and 25°C (68° to 77°F). This temperature range helps maintain the product's effectiveness and safety. It's also important to keep the original carton, as it contains valuable information about the product's labeling that you may need for future reference.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Oxymetazoline HCL 0.05%?

Oxymetazoline HCL 0.05% is an extra moisturizing nasal spray that temporarily relieves nasal congestion.

What conditions does this nasal spray relieve?

It relieves nasal congestion due to common cold, hay fever, sinusitis, and upper respiratory allergies.

How does Oxymetazoline work?

It works by shrinking swollen membranes in the nasal passages, allowing you to breathe more freely.

How long does the relief last?

The spray provides fast, powerful relief for up to 12 hours.

What is the recommended dosage for adults and children aged 6 to under 12?

The recommended dosage is 2 or 3 sprays in each nostril not more than every 10 to 12 hours, with a maximum of 2 doses in any 24-hour period.

What should I do if I have children under 6 years of age?

Consult a doctor before using the spray for children under 6 years of age.

Are there any side effects?

Temporary discomfort such as burning, stinging, sneezing, or increased nasal discharge may occur.

How should I use the nasal spray?

Do not tilt your head backward while spraying, and wipe the nozzle clean after use.

What should I do if symptoms persist?

Stop use and ask a doctor if symptoms persist.

Are there any contraindications for using this spray?

No specific contraindications are mentioned, but consult a doctor if you have certain health conditions.

What should I do if I accidentally swallow the spray?

If swallowed, get medical help or contact a Poison Control Center right away.

How should I store Oxymetazoline?

Store the spray between 20° and 25°C (68° to 77°F) and retain the carton for future reference.

Packaging Info

Below are the non-prescription pack sizes of 12 Hour Nasal Decongestant Extra Moisturizing (nasal spray). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 12 Hour Nasal Decongestant Extra Moisturizing.
Details

Drug Information (PDF)

This file contains official product information for 12 Hour Nasal Decongestant Extra Moisturizing, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

WinCo Foods Extra Moisturizing Nasal Spray contains 0.05% oxymetazoline hydrochloride as its active ingredient. This formulation is indicated for the fast and powerful relief of nasal congestion, providing up to 12 hours of relief. The product is available in a 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 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 use.

When administering 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 administration of the spray. 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 use the product for more than three consecutive days. Prolonged use may lead to a recurrence or worsening of nasal congestion.

Warnings and Precautions

In the event of accidental ingestion, immediate medical assistance should be sought. Healthcare professionals are advised to instruct patients to contact a Poison Control Center or seek emergency medical help without delay.

Patients should discontinue use and consult their healthcare provider if symptoms persist. It is essential for healthcare professionals to monitor patients closely and provide appropriate guidance based on individual clinical circumstances.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. In clinical trials and postmarketing experiences, various reactions have been reported, necessitating careful monitoring.

In the event of persistent symptoms, patients are advised to stop use and consult a healthcare professional. Additionally, individuals with specific pre-existing conditions should seek medical advice before initiating treatment. These conditions include heart disease, high blood pressure, diabetes, thyroid disease, and difficulties in urination due to an enlarged prostate gland.

It is crucial for patients to remain vigilant regarding their health status while using this medication and to communicate any concerns with their healthcare provider.

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 12 Hour Nasal Decongestant Extra Moisturizing (nasal spray). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 12 Hour Nasal Decongestant Extra Moisturizing.
Details

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 available 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.

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. 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

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare providers should evaluate the potential risks and benefits when considering this medication for lactating patients.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is important to monitor renal function tests in these patients to ensure safety and efficacy. Specifically, patients with reduced creatinine clearance may require a reduced dose to avoid potential toxicity. Additionally, special monitoring is advised for patients with significant renal impairment to manage their treatment effectively.

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 general principles of management in cases of suspected overdose.

It is essential to monitor the patient 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 compound in these areas.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients 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 doctor 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 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 a carton that should be retained for future reference on the full labeling. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F) to ensure its stability and efficacy. Proper storage conditions must be maintained to preserve the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 12 Hour Nasal Decongestant Extra Moisturizing, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for 12 Hour Nasal Decongestant Extra Moisturizing, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.