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Severe 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 2023
Label revision date
December 9, 2025
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 2023
Label revision date
December 9, 2025
Manufacturer
ALAINA HEALTHCARE PRIVATE LIMITED
Registration number
M012
NDC root
73492-715
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

SEVERE Nasal Spray is a nasal decongestant that contains oxymetazoline hydrochloride (0.05%), which helps to temporarily relieve nasal congestion caused by colds, hay fever, or other upper respiratory allergies. It also alleviates sinus congestion and pressure, making it easier for you to breathe.

This nasal spray is designed with a super-fine moisturizing mist and includes soothing aloe to provide comfort during use. Each bottle contains 0.5 fluid ounces (15 mL) of the spray, making it a convenient option for managing nasal congestion.

Uses

If you're dealing with nasal congestion from a cold, hay fever, or other upper respiratory allergies, this medication can help provide temporary relief. It works by easing the swelling in your nasal passages, making it easier for you to breathe.

Additionally, if you're experiencing sinus congestion and pressure, this medication can also help alleviate those uncomfortable symptoms. It's designed to make you feel more comfortable when you're dealing with these common respiratory issues.

Dosage and Administration

When using this medication, adults and children aged 6 years and older can take 2 or 3 sprays in each nostril. You should wait at least 10 to 12 hours before taking another dose, and it’s important not to exceed 2 doses in a 24-hour period.

If you have a child between the ages of 2 and 6, it’s best to consult a doctor before using this medication. For children under 2 years old, you should not use this product at all. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this product 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 this product 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 product only as directed. If you have any concerns or questions about its use, please consult a healthcare professional for guidance.

Side Effects

You may experience some temporary discomfort while using this product, such as burning, stinging, sneezing, or increased nasal discharge. If these symptoms persist, it's important to stop using the product and consult a doctor.

Before using this product, talk to your doctor if you have any of the following conditions: heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Remember not to exceed the recommended dosage or use the product for more than three days, as doing so may worsen nasal congestion. Additionally, sharing this product with others can spread infection, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

Before using this medication, it’s important to consult your doctor if you have any of the following conditions: heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. These conditions may affect how the medication works for you.

If your symptoms do not improve, you should stop using the medication and reach out to your doctor for further advice. Additionally, if you accidentally swallow the medication, seek medical help immediately or contact a Poison Control Center. Your safety is a priority, so don’t hesitate to get help if you need it.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center. They can provide guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to reach out for help. Remember, it’s always better to be safe and get professional advice in these situations.

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 are considering this medication for your child, it's important to know the age guidelines. For children aged 2 to under 6 years, you should consult a doctor before use. For children under 2 years old, this medication should not be used at all.

For children aged 6 years and older, you can administer 2 or 3 sprays in each nostril, but make sure to do this no more than every 10 to 12 hours. It's crucial not to exceed 2 doses within a 24-hour period. Always supervise your child during use to ensure their safety.

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 prioritize open communication with your healthcare team to ensure safe and effective treatment, especially as you navigate the complexities of aging and medication management.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication, especially if you experience difficulty urinating due to an enlarged prostate gland. Your healthcare provider can help determine if this medication is safe for you and may suggest adjustments to your dosage or monitoring based on your kidney function. Always prioritize open communication with your doctor regarding your kidney health and any medications you are considering.

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 (liver issues).

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 or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the safety and effectiveness of your product, it’s important to store it at a temperature that does not exceed 25°C (77°F). Keeping it within this temperature range helps maintain its quality and performance.

When handling the product, make sure to follow any specific instructions provided to avoid contamination or damage. Always ensure that your hands and any surfaces are clean to maintain a safe environment for use. If you have any questions about disposal or further handling instructions, please refer to the guidelines provided with your product.

Additional Information

You can use this medication through your nose (nasal administration). For adults and children aged 6 years and older, the recommended dose is 2 or 3 sprays in each nostril, but you should not use it more often than every 10 to 12 hours, and do not exceed 2 doses in a 24-hour period. If your child is between 2 and under 6 years old, consult a doctor before use. This medication is not recommended for children under 2 years old.

FAQ

What is SEVERE Nasal Spray used for?

SEVERE Nasal Spray is a nasal decongestant that temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies.

What is the active ingredient in SEVERE Nasal Spray?

The active ingredient in SEVERE Nasal Spray is Oxymetazoline HCl 0.05%.

How should I use SEVERE Nasal Spray?

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

What are the side effects of SEVERE Nasal Spray?

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

Are there any warnings for using SEVERE Nasal Spray?

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

How long can I use SEVERE Nasal Spray?

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

What should I do if I swallow SEVERE Nasal Spray?

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

Is SEVERE Nasal Spray safe during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using SEVERE Nasal Spray.

What is the volume of SEVERE Nasal Spray?

SEVERE Nasal Spray comes in a volume of 0.5 FL OZ (15mL).

Packaging Info

Below are the non-prescription pack sizes of Severe Nasal (oxymetazoline hydrochloride 0.05%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Severe Nasal.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with colds, hay fever, or other upper respiratory allergies. Additionally, it provides relief from sinus congestion and pressure.

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

Dosage and Administration

For adults and children aged 6 years and older, the recommended dosage is 2 to 3 sprays in each nostril. Dosing should not occur more frequently than every 10 to 12 hours, and it is important not to exceed 2 doses within a 24-hour period.

For children aged 2 to under 6 years, it is advised to consult a physician for appropriate dosing recommendations. The product is not indicated for use in children under 2 years of age.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage or utilize it for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. It is essential to adhere strictly to the directed usage guidelines.

Warnings and Precautions

Healthcare professionals are advised to exercise caution when recommending this product to patients with specific medical conditions. Prior to use, it is imperative to consult a physician if the patient has a history of heart disease, thyroid disease, diabetes, high blood pressure, or experiences difficulty urinating due to an enlarged prostate gland.

In the event that symptoms persist despite use, it is essential to discontinue the product and seek medical advice.

In cases of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients using this product may experience temporary discomfort, which can include symptoms such as burning, stinging, sneezing, or increased nasal discharge. These reactions are generally mild and transient.

It is advised that patients discontinue use and consult a healthcare professional if symptoms persist. Additionally, patients should seek medical advice prior to use if they have a history of heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

Patients are cautioned not to exceed the recommended dosage and to refrain from using this product for more than three days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Furthermore, sharing this product among multiple users may increase the risk of spreading infection.

In the event of accidental ingestion, patients should seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Severe Nasal (oxymetazoline hydrochloride 0.05%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Severe Nasal.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication. For children aged 2 to under 6 years, it is advised to consult a doctor before use.

In children 6 years and older, 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, and adult supervision is required 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 efficacy, 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. 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 should consult a healthcare professional prior to use, particularly if they experience difficulties urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 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 or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has not been explicitly detailed in the provided text. 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. In the event of swallowing the product, patients 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. It is important to emphasize that patients must not exceed the recommended dosage and should not use the product for more than three days. They should use the product only as directed, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patients may experience temporary discomfort, including burning, stinging, sneezing, or increased nasal discharge while using the product. Additionally, healthcare providers should caution patients that the use of this container by more than one person may increase the risk of spreading infection.

Before using the product, patients should be encouraged to consult a doctor if they have any of the following conditions: heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature not exceeding 25°C to maintain its integrity and efficacy. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs should be observed to prevent any compromise to the product's quality during storage and transportation.

Additional Clinical Information

The medication is administered via the nasal route. For adults and children aged 6 years and older, it is recommended to use 2 or 3 sprays in each nostril, with a frequency not exceeding every 10 to 12 hours, and a maximum of 2 doses within a 24-hour period. For children aged 2 to under 6 years, consultation with a doctor is advised before use, while the medication is not recommended for children under 2 years of age.

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 Severe 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 Severe 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

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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.