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Nostrilla

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Active ingredient
Oxymetazoline Hydrochloride 0.05 mg/100 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Spray, Metered
Route
Nasal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2009
Label revision date
October 25, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride 0.05 mg/100 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Spray, Metered
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 2009
Label revision date
October 25, 2024
Manufacturer
Insight Pharmaceuticals LLC
Registration number
M012
NDC root
63736-730
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Nōstrilla® is a nasal decongestant that contains oxymetazoline hydrochloride, which is a medication designed to temporarily relieve nasal congestion caused by conditions such as colds, hay fever, and upper respiratory allergies. It works by helping to clear nasal passages and shrink swollen membranes, allowing for easier breathing through the nose.

This solution comes in a 1/2 fluid ounce (15 mL) bottle and is specifically formulated to provide quick relief from the discomfort of nasal congestion, helping you feel more comfortable and breathe more freely.

Uses

If you're dealing with nasal congestion from a cold, hay fever, or upper respiratory allergies, this medication can help. It works by temporarily relieving your stuffy nose, making it easier for you to breathe. By helping to clear your nasal passages and shrinking swollen membranes, you can experience a more comfortable breathing experience through your nose.

Dosage and Administration

When using this medication, adults and children aged 6 to under 12 years should take 2 or 3 sprays in each nostril, but not more often than every 10 to 12 hours. It's important not to exceed 2 doses within a 24-hour period. If your child is under 6 years old, you should consult a doctor before use.

To administer the medication, start by removing the protective cap from the bottle. Next, align the rail grooves and prime the pump by pressing it down firmly several times. Hold the bottle with your thumb at the base and the nozzle between your first and second fingers. With your head upright, gently insert the nozzle into your nostril. Finally, press the pump down 2 or 3 times while sniffing deeply to ensure the medication is properly delivered.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should never exceed the recommended dosage, as doing so can lead to unwanted effects. Additionally, avoid using the medication for more than three days. Using it longer than directed may cause your nasal congestion to come back or even worsen.

Always follow the instructions provided and use the medication only as directed. If you have any questions or concerns about your treatment, don't hesitate to reach out to your healthcare provider for guidance.

Side Effects

You may experience some temporary discomfort when using this product, which can include burning, stinging, sneezing, or an increase in nasal discharge. If you use it frequently or for a long time, you might find that nasal congestion returns or worsens.

If your symptoms continue, 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, thyroid disease, high blood pressure, diabetes, or difficulty urinating due to an enlarged prostate gland. While using the product, make sure not to exceed the recommended dosage. You may experience temporary discomfort, such as burning, stinging, sneezing, or increased nasal discharge. Remember, do not use it for more than three days, as frequent or prolonged use can lead to worsening nasal congestion. Also, sharing this container with others can spread infections.

If your symptoms persist, stop using the product and contact your doctor. In case of accidental swallowing, seek emergency medical help immediately or call the Poison Control Center at 1-800-222-1222. Lastly, keep this product out of reach of children to ensure their safety.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

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 use it with adult supervision. The recommended dosage is 2 or 3 sprays in each nostril, but make sure not to use it more than once every 10 to 12 hours. Additionally, do not exceed 2 doses in a 24-hour period to ensure your child's safety. Always follow these guidelines to help keep your child healthy.

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, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 should be used if you have hepatic impairment (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medication or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

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° and 77°F). It's important to avoid exposing it to excessive heat or freezing conditions, as these can affect its effectiveness.

Make sure to keep the original carton, as it contains important information about the product. This will help you reference the full drug facts whenever needed. Handling the product with care will also contribute to its safety and efficacy.

Additional Information

No further information is available.

FAQ

What is Nōstrilla®?

Nōstrilla® is an oxymetazoline HCl nasal solution used as a nasal decongestant.

What does Nōstrilla® do?

It temporarily relieves nasal congestion due to a cold, hay fever, or upper respiratory allergies by helping to clear nasal passages and shrink swollen membranes.

How should I use Nōstrilla®?

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 years should consult a doctor.

What are the side effects of Nōstrilla®?

Temporary discomfort such as burning, stinging, sneezing, or increased nasal discharge may occur. Frequent or prolonged use may worsen nasal congestion.

Are there any warnings for using Nōstrilla®?

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

How long can I use Nōstrilla®?

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

What should I do if symptoms persist?

If symptoms persist, stop using Nōstrilla® and consult a doctor.

What should I do in case of accidental ingestion?

If swallowed, seek emergency medical help or contact a Poison Control Center immediately.

How should I store Nōstrilla®?

Store Nōstrilla® between 20° – 25°C (68° – 77°F) and avoid excessive heat or freezing.

Is Nōstrilla® safe during pregnancy or breastfeeding?

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

Packaging Info

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

Packaging configurations for Nostrilla.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Nōstrilla® is a nasal decongestant formulation containing oxymetazoline hydrochloride as the active ingredient. It is presented as a nasal solution in a volume of 1/2 fluid ounce (15 mL).

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with colds, hay fever, and upper respiratory allergies. It aids in clearing nasal passages and reduces swollen membranes, thereby restoring freer breathing through the nose.

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 not 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 physician is advised prior to use.

The administration method requires the following steps: First, squeeze and unscrew the bottle to remove the protective cap. Next, align the rail grooves and prime the pump by firmly depressing it several times. The bottle should be held with the thumb at the base and the nozzle positioned between the first and second fingers. With the head in an upright position, insert the nozzle into the nostril. Finally, depress the pump two or three times, ensuring to press all the way down, while simultaneously sniffing deeply.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the following guidelines to ensure safe use:

  • Do not exceed the recommended dosage.

  • Do not use for more than 3 days. Use only as directed, 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. Prior to use, it is imperative to consult a physician if the patient has any of the following conditions: heart disease, thyroid disease, high blood pressure, diabetes, or difficulty urinating due to an enlarged prostate gland.

When administering this product, it is essential to adhere strictly to the recommended dosage. Patients may experience temporary discomfort, which can manifest as burning, stinging, sneezing, or an increase in nasal discharge. It is crucial to limit the use of this product to no more than three consecutive days, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. Additionally, sharing this container among multiple users may pose a risk of spreading infection.

Healthcare professionals should advise patients to discontinue use and seek medical advice if symptoms persist. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Finally, it is vital to keep this product out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients using this product may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. These reactions are generally mild and transient.

It is important to note that frequent or prolonged use of the product may lead to a recurrence or worsening of nasal congestion.

Patients are advised to discontinue use and consult a healthcare professional if symptoms persist.

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

Packaging configurations for Nostrilla.
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

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 therapeutic response, 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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 drug. Consequently, there are no 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 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 without delay. Contacting a Poison Control Center at 1-800-222-1222 is recommended for further guidance and support.

Prompt intervention is essential to manage potential complications associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and address any adverse effects that may arise.

Management procedures should include a thorough evaluation of the patient's condition, monitoring vital signs, and providing supportive care as necessary. It is imperative that healthcare professionals remain vigilant and act swiftly to mitigate any risks associated with 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 limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

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

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to stop use and consult a doctor if symptoms persist. When using this product, it is crucial to not exceed the recommended dosage. Patients may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. It is important to note that the product should not be used for more than three days and should only be used as directed. Frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Additionally, healthcare providers should caution patients that using this container by more than one person may increase the risk of spreading infection. Patients should also be encouraged to consult a doctor before use if they have any of the following conditions: heart disease, thyroid disease, high blood pressure, diabetes, or trouble urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in a carton that should be retained for reference to the full drug facts. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to excessive heat or freezing conditions to maintain the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Nostrilla, 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 Nostrilla, 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.

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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.