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Sudafed Om Sinus Severe Original

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Active ingredient
Oxymetazoline Hydrochloride 50 mg/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
December 12, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride 50 mg/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
December 12, 2024
Manufacturer
Kenvue Brands LLC
Registration number
M012
NDC root
50580-787
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

SUDAFED®OM is a nasal spray that contains oxymetazoline HCl (0.05%), designed to provide fast and powerful relief from nasal congestion caused by colds or allergies. This maximum strength formulation offers up to 12 hours of relief, making it effective for symptoms associated with the common cold, hay fever, and upper respiratory allergies.

The spray works by temporarily shrinking swollen nasal membranes, which helps to ease breathing and relieve sinus congestion and pressure. With a convenient volume of 1 fl oz (30 mL), SUDAFED®OM is a helpful 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 use 2 or 3 sprays in each nostril, but not more often than every 10 to 12 hours. It's important to remember that you should not 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, start by pushing down firmly on the cap and turning it counterclockwise. When you're ready to spray, squeeze the bottle quickly and firmly, making sure not to tilt your head backward while doing so. After using the spray, wipe the nozzle clean and secure the cap to keep it safe for the next use.

What to Avoid

It's important to use this medication responsibly to avoid potential issues. 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. Additionally, sharing this medication with others can increase the risk of spreading infections, so it's best to keep it for your personal use only.

Side Effects

You may experience some temporary discomfort while using this product, which can include 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 medication, 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 dosage 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 medication can lead to the spread of infection.

If your symptoms do not improve, stop using the medication and contact your doctor. Keep this product out of reach of children; if swallowed, seek medical help immediately or call Poison Control at 1-800-222-1222.

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 with 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 often than every 10 to 12 hours, and do not exceed 2 doses in a 24-hour period. Always follow these guidelines to ensure your child's safety and well-being.

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.

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 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 all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its 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.

By following these simple storage guidelines, you can help ensure that your product remains safe and effective for use.

Additional Information

No further information is available.

FAQ

What is SUDAFED®OM used for?

SUDAFED®OM is used to temporarily relieve nasal congestion due to the common cold, hay fever, and upper respiratory allergies, as well as sinus congestion and pressure.

How long does the relief from SUDAFED®OM last?

The relief from SUDAFED®OM can last up to 12 hours.

What is the active ingredient in SUDAFED®OM?

The active ingredient in SUDAFED®OM is Oxymetazoline HCI 0.05%.

How should I use SUDAFED®OM?

To use SUDAFED®OM, push firmly down on the cap and turn counterclockwise. Squeeze the bottle quickly and firmly to spray, and do not tilt your head backward while spraying.

What are the dosage instructions for adults and children aged 6 to under 12?

Adults and children aged 6 to under 12 should use 2 or 3 sprays in each nostril not more often than every 10 to 12 hours, and should not exceed 2 doses in any 24-hour period.

Are there any side effects associated with SUDAFED®OM?

Temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur when using SUDAFED®OM.

What should I do if symptoms persist?

If symptoms persist, you should stop using SUDAFED®OM and ask a doctor.

Can I use SUDAFED®OM if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using SUDAFED®OM.

What precautions should I take before using SUDAFED®OM?

You should ask 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 should I store SUDAFED®OM?

SUDAFED®OM should be stored at 20-25°C (68-77°F).

Packaging Info

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

Packaging configurations for Sudafed Om Sinus Severe Original.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NDC 50580-787-01, SUDAFED®OM, contains Oxymetazoline HCl at a concentration of 0.05% and is classified as a nasal decongestant. This formulation is designed for use as a nasal spray, providing fast and powerful relief from congestion associated with colds or allergies. The product is available in a maximum strength dosage form, with a volume of 1 fluid ounce (30 mL), offering up to 12 hours of relief.

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 medication acts to shrink swollen nasal membranes, facilitating easier breathing.

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

Dosage and Administration

Adults and children aged 6 to under 12 years should receive 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 physician is recommended prior to use.

To administer the medication, the healthcare professional should instruct the patient to push firmly down on the cap and turn it counterclockwise to open. While spraying, the patient should squeeze the bottle quickly and firmly without tilting the head backward. After use, the nozzle should be wiped clean, and the cap should be securely replaced.

Contraindications

Use is contraindicated in the following situations:

  • Use is not recommended for more than 3 consecutive days due to the risk of nasal congestion recurrence or worsening.

  • The product should not be used in cases where the dosage exceeds the directed amount.

  • Sharing this container among multiple individuals is contraindicated as it may facilitate the spread of infection.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.

Patients should be advised to consult a physician prior to use 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. These conditions may increase the risk of adverse effects and require careful consideration before initiating treatment.

It is imperative that patients adhere strictly to the recommended dosage. The medication should not be used for more than three consecutive days, as prolonged or excessive use may lead to a rebound effect, resulting in worsened nasal congestion. Patients may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge during use. Additionally, the sharing of this medication container among multiple users is discouraged, as it may facilitate the transmission of infections.

Patients should be instructed to discontinue use and consult a healthcare provider if symptoms persist despite treatment.

In case of accidental ingestion, it is crucial to keep the medication out of reach of children. If swallowed, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

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 Sudafed Om Sinus Severe Original (oxymetazoline hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sudafed Om Sinus Severe Original.
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 during administration for this age group.

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 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 should consult a healthcare professional prior to use, particularly if they experience difficulty 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 patient's specific condition.

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 event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals are advised to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Temporary discomfort may occur, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. No additional relevant information regarding nonclinical toxicology or animal pharmacology and toxicology is available.

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to stop using the product and consult a doctor if symptoms persist. It is important to emphasize that while using this product, patients must not exceed the directed dosage and should not use it for more than three consecutive days. 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. Additionally, inform patients that sharing this container with others may increase the risk of spreading infection.

Healthcare providers should also recommend that patients 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 packaging that includes the relevant NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy. Healthcare professionals are advised to retain the carton for future reference regarding the full labeling information. Special handling requirements are not specified; however, standard precautions should be taken to maintain the integrity of the product during storage.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Sudafed Om Sinus Severe Original, 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 Sudafed Om Sinus Severe Original, 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.