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Nasal

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Active ingredient
Oxymetazoline Hydrochloride 0.05 g/100 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Spray
Route
Nasal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
May 16, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride 0.05 g/100 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Spray
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 2024
Label revision date
May 16, 2024
Manufacturer
Bi-Mart
Registration number
M012
NDC root
37835-995
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 hydrochloride is a nasal spray that acts as a long-lasting nasal decongestant. It provides fast relief from nasal congestion caused by conditions such as the common cold, hay fever, and upper respiratory allergies, helping you breathe more freely for up to 12 hours. This medication works by temporarily shrinking swollen nasal membranes, which alleviates sinus congestion and pressure.

You may find oxymetazoline hydrochloride similar to the active ingredient in Afrin®, making it a familiar option for those seeking quick relief from nasal discomfort.

Uses

If you're dealing with nasal congestion from a common cold, hay fever, or upper respiratory allergies, this medication can help provide temporary relief. It works by shrinking swollen nasal membranes, making it easier for you to breathe. Additionally, it can alleviate sinus congestion and pressure, helping you feel more comfortable.

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 no more often than every 10 to 12 hours, and it's important not to exceed 2 doses in a 24-hour period. If your child is under 6 years old, please consult a doctor before use.

To apply the spray, hold the bottle upright and squeeze it quickly and firmly. Make sure not to tilt your head backward while spraying. After each use, remember to wipe the nozzle clean to keep it in good condition.

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, and always follow the directions provided. Using it more than directed or for an extended period can lead to a worsening of nasal congestion, which is the very issue you may be trying to alleviate.

To avoid potential complications, make sure to adhere strictly to the recommended usage guidelines. If you have any questions or concerns about how to use this medication, don't hesitate to reach out to your healthcare provider for guidance.

Side Effects

When using this product, you may experience temporary discomfort, which can include sensations like burning, stinging, sneezing, or an increase in nasal discharge. These side effects are generally mild and should resolve on their own.

However, if your symptoms persist, it’s important to stop using the product and consult a doctor for further advice.

Warnings and Precautions

Before using this product, it's important to consult your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Always follow the directions carefully—do not exceed the recommended dose or use it for more than three days, as doing so may worsen nasal congestion. You might experience temporary discomfort like burning, stinging, sneezing, or increased nasal discharge. Additionally, sharing this product with others can lead to the spread of infection.

If your symptoms do not improve, stop using the product and contact your doctor for further advice. Keep this medication out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child under 6 years old, it's important to consult a doctor before using this medication. For children aged 6 to under 12 years, you can administer 2 or 3 sprays in each nostril, but make sure to do this only every 10 to 12 hours. It's crucial not to exceed 2 doses within a 24-hour period to ensure their safety. Always supervise your child during use to ensure proper administration.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your kidney function might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific condition. They can help determine the best approach based on your kidney health.

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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the seal around the cap is intact and undamaged before use. If the seal is missing or damaged, do not use the product. It's also a good idea to keep the carton, as it contains important information you may need later.

For proper storage, keep the product in a cool, dry place at a temperature between 20° to 25°C (68°F and 77°F). This helps maintain its quality and effectiveness.

Additional Information

You should use this medication through the nasal route. For adults and children aged 6 to under 12 years (with adult supervision), the recommended dosage is 2 or 3 sprays in each nostril, not more than every 10 to 12 hours, and do not exceed 2 doses in a 24-hour period. If the patient is under 6 years old, consult a doctor for guidance on use.

FAQ

What is Oxymetazoline hydrochloride?

Oxymetazoline hydrochloride is a long-lasting nasal spray that acts as a nasal decongestant, providing fast relief from nasal congestion for up to 12 hours.

What conditions does Oxymetazoline hydrochloride relieve?

It temporarily relieves nasal congestion due to the common cold, hay fever, and upper respiratory allergies, as well as sinus congestion and pressure.

How should I use Oxymetazoline hydrochloride?

For adults and children aged 6 to under 12 years, use 2 or 3 sprays in each nostril every 10 to 12 hours, not exceeding 2 doses in 24 hours. Children under 6 should consult a doctor.

What are the side effects of using Oxymetazoline hydrochloride?

Temporary discomfort such as burning, stinging, sneezing, or increased nasal discharge may occur. If symptoms persist, stop use and consult a doctor.

Are there any warnings associated with Oxymetazoline hydrochloride?

Yes, consult a doctor before use if you have heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland.

How long can I use Oxymetazoline hydrochloride?

Do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to recur or worsen.

What should I do if I accidentally swallow Oxymetazoline hydrochloride?

Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Is Oxymetazoline hydrochloride safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use.

What should I do if the seal around the cap is missing or damaged?

Do not use the product if the seal is missing or damaged.

How should I store Oxymetazoline hydrochloride?

Store the product between 20° to 25°C (68°F and 77°F).

Packaging Info

Below are the non-prescription pack sizes of Nasal (oxymetazoline hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nasal.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Oxymetazoline hydrochloride 0.05% is a nasal decongestant formulated to provide fast relief from nasal congestion associated with colds and allergies. This solution is presented in a dosage form of 1 fluid ounce (30 mL). The active ingredient, oxymetazoline hydrochloride, acts to alleviate nasal congestion for up to 12 hours.

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 drug acts to shrink swollen nasal membranes, 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 before administration.

To properly administer the spray, the healthcare professional should instruct the patient to squeeze the bottle quickly and firmly while ensuring that the head is not tilted backward during the spraying process. After use, the nozzle should be wiped clean to maintain hygiene and prevent blockage.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage or duration of use. Specifically, it should not be used for more than three consecutive days, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product, particularly in patients with specific underlying health conditions. It is imperative to consult a physician prior to use in individuals with a history of heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland.

When administering this product, adherence to the recommended dosage is crucial. Patients should not exceed the directed use and should limit application to a maximum of three consecutive days. Prolonged or frequent use may lead to a rebound effect, resulting in worsened nasal congestion. Users may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is important to note that sharing this product among multiple users may facilitate the spread of infection.

Patients should be advised to discontinue use and consult a healthcare provider if symptoms persist. Furthermore, this product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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

Packaging configurations for Nasal.
Details

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

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 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 are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved, and it is essential to monitor the patient closely for any adverse effects.

Management of overdosage typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on the severity of symptoms and the substance involved.

In all cases of suspected overdosage, timely communication with poison control and adherence to established protocols are recommended to ensure optimal patient 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 use of the compound in question.

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 keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if symptoms persist. When using this product, it is crucial to adhere to the following guidelines: do not exceed the recommended dosage, and do 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, including burning, stinging, sneezing, or an increase in nasal discharge. It is important to inform patients that sharing this container with others may increase the risk of spreading infection.

Additionally, healthcare providers should encourage patients to consult a doctor before using this product 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 a secure package, and it is imperative that it is not used if the seal around the cap is missing or damaged. Healthcare professionals are advised to retain the carton for complete information regarding the product.

For optimal storage conditions, the product should be maintained at a temperature range of 20° to 25°C (68°F to 77°F). Proper handling and storage are essential to ensure the integrity and efficacy of the product.

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 before 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 Nasal, 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 Nasal, 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.