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Sound Body Nasal

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This product has been discontinued

Active ingredient
Oxymetazoline Hydrochloride 0.05 g/100 mL
Other brand names
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 2016
Label revision date
October 24, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride 0.05 g/100 mL
Other brand names
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 2016
Label revision date
October 24, 2024
Manufacturer
Big Lots Stores, Inc.
Registration number
M012
NDC root
50594-017
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 is a nasal decongestant that provides fast and powerful relief from nasal congestion caused by colds, hay fever, and upper respiratory allergies. This maximum strength nasal spray works by temporarily shrinking swollen nasal membranes, allowing you to breathe more freely. It also helps relieve sinus congestion and pressure, offering up to 12 hours of relief in a convenient 1 fluid ounce (30 mL) bottle.

As the #1 doctor-recommended active ingredient in adult nasal sprays, Oxymetazoline HCl is a trusted option for those seeking quick relief from nasal discomfort. Whether you're dealing with seasonal allergies or a common cold, this spray can help you feel more comfortable and breathe easier.

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. You can do this no more than every 10 to 12 hours, but make sure not to exceed 2 doses in a 24-hour period. If your child is under 6 years old, it’s important to 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, but remember 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 next time.

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

If you experience any symptoms that persist while using this medication, it's important to stop use and consult your doctor. Before starting this medication, you should talk to your healthcare provider 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.

Currently, there are no specific side effects or additional adverse reactions listed for this medication. However, always stay informed and communicate with your doctor about any health concerns you may have.

Warnings and Precautions

If you accidentally swallow this medication, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your safety is a priority, so don’t hesitate to reach out for assistance.

You should stop using this medication and consult your doctor if your symptoms continue despite treatment. It’s essential to keep an open line of communication with your healthcare provider to ensure you receive the best care possible.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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

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 at least 10 to 12 hours apart and not to exceed 2 doses in a 24-hour period.

For children under 6 years of age, you should consult a doctor before use. This ensures that the medication is safe and appropriate for your child's specific needs. Always prioritize your child's health and safety by following these guidelines.

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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Specifically, if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste), you should be closely monitored by your healthcare provider.

Before starting treatment and during your care, your renal function will be tested to ensure your kidneys are working properly. If you have moderate to severe renal impairment, a lower dose of the medication is recommended to help manage your condition safely. Always discuss any concerns with your doctor to ensure the best care for your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that your condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Additionally, your healthcare provider will likely monitor your liver function tests (which check how well your liver is working) more closely if you have a pre-existing liver condition. Special precautions will be taken when administering the drug to ensure your safety. Always discuss any concerns with your doctor to ensure the best care for your health.

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 provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might affect each other or any tests you may undergo. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°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 simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should use this medication through your nose (nasal administration). For adults and children aged 6 to under 12 years, the recommended dose is 2 or 3 sprays in each nostril, but you should not use it more than once 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.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. Be cautious, as sharing this container with others can lead to the spread of infection. In case of accidental swallowing, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Oxymetazoline HCl used for?

Oxymetazoline HCl is a nasal decongestant that temporarily relieves nasal congestion due to the common cold, hay fever, and upper respiratory allergies.

How long does the relief last?

It provides fast, powerful congestion 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 often than every 10 to 12 hours, with a maximum of 2 doses in any 24-hour period.

Can children under 6 use this medication?

Children under 6 years of age should ask a doctor before use.

What should I do if symptoms persist?

You should stop using the medication and ask a doctor if symptoms persist.

Are there any warnings associated with Oxymetazoline HCl?

If swallowed, seek medical help or contact a Poison Control Center immediately. Additionally, use only as directed and do not use for more than 3 days.

What should I do if I am pregnant or breastfeeding?

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

What are the storage conditions for this medication?

Store Oxymetazoline HCl at 20-25°C (68-77°F) and retain the carton for future reference on full labeling.

Packaging Info

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

Packaging configurations for Sound Body Nasal.
Details

Drug Information (PDF)

This file contains official product information for Sound Body 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 and powerful relief from nasal congestion associated with colds and allergies. This solution is designed for intranasal administration and offers up to 12 hours of relief. The product is supplied in a 1 fluid ounce (30 mL) container.

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

Adults and children aged 6 to under 12 years of age, when administered under adult supervision, may receive 2 or 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 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. When ready to spray, the patient should squeeze the bottle quickly and firmly while ensuring that the head is not tilted backward during administration. After use, the nozzle should be wiped clean, and the cap should be securely replaced.

Contraindications

Use is contraindicated in patients who exceed the recommended dosage or duration of use. Specifically, the product should not be used for more than three days, as frequent or 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 contact a Poison Control Center at 1-800-222-1222 for guidance.

Patients should discontinue use and consult a physician if symptoms persist. Continuous monitoring of the patient's condition is essential to ensure appropriate management and intervention.

Side Effects

Patients should be monitored for any adverse reactions during treatment. Currently, there are no specific side effects listed in the available data. However, it is advised that patients stop use and consult a doctor if symptoms persist.

Before initiating treatment, patients should seek medical advice if they have a history of heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland. These conditions may necessitate closer observation or alternative therapeutic strategies.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Sound Body Nasal.
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 not to 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 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that patients with reduced creatinine clearance are closely monitored throughout their treatment. Additionally, renal function tests should be performed prior to and during treatment in these patients. A reduced dose is recommended for patients with moderate to severe renal impairment to ensure safety and efficacy.

Hepatic Impairment

Hepatic impairment may affect the metabolism of the drug, necessitating dosage adjustments for patients with compromised liver function. It is essential to monitor liver function tests in patients with pre-existing liver conditions to ensure safety and efficacy. Special precautions should be taken when administering the drug to this population, as their altered metabolic capacity may influence therapeutic outcomes and the risk of adverse effects.

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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment and follow-up care.

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. There is no additional information available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of temporary discomfort, including burning, stinging, sneezing, and an increase in nasal discharge. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

Patients should be advised to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222 if the product is swallowed. It is important to instruct patients not to exceed the recommended dosage and to limit use to no more than three days. They should be informed that using the product more frequently or for an extended period may lead to a recurrence or worsening of nasal congestion.

Patients may experience temporary discomfort, which can include symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. It is crucial to communicate that sharing this container with others may pose a risk of spreading infection.

Healthcare providers should encourage patients to consult with 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. This precaution is essential to ensure the safe and effective use of the product.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to retain the carton for future reference regarding the full labeling information, ensuring that all necessary details are readily accessible for proper handling and administration.

Additional Clinical Information

The medication is administered via the nasal route. For adults and children aged 6 to under 12 years, the recommended dosage is 2 or 3 sprays in each nostril, not to be used more frequently than every 10 to 12 hours, with a maximum of 2 doses in a 24-hour period. For children under 6 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to note that sharing this medication container among multiple users may lead to the spread of infection. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Sound Body 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 Sound Body 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.