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Signature Care Nasal Decongestant

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Active ingredient
Oxymetazoline Hydrochloride 0.05 g/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 2019
Label revision date
August 27, 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, 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 2019
Label revision date
August 27, 2024
Manufacturer
Safeway
Registration number
M012
NDC root
21130-813
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 0.05% is a nasal decongestant that provides fast and powerful relief from nasal congestion caused by the common cold, hay fever, and upper respiratory allergies. It works by temporarily shrinking swollen nasal membranes, allowing you to breathe more freely. This product is the #1 doctor-recommended active ingredient for adult nasal sprays and is designed to prevent dripping from your nose or down your throat, making it a convenient option for congestion relief.

In addition to its effectiveness for colds and allergies, Oxymetazoline Hydrochloride is available in a pump mist formulation, ensuring quality and ease of use. With the added benefit of menthol, it offers maximum strength relief for sinus congestion and pressure.

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, allowing you to breathe more freely. Additionally, it can alleviate sinus congestion and pressure, making it easier for you to feel comfortable.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. To prepare it for use, hold the white tabs, squeeze the grooved area of the cap firmly, and turn it counterclockwise. If you’re using it for the first time, you’ll need to prime the metered pump by pressing it down several times until you see a spray.

For adults and children aged 6 to under 12 years, you can use 2 or 3 sprays in each nostril, but make sure not to do this more often than every 10 to 12 hours. 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 using this medication. When you’re ready to spray, hold the bottle with your thumb at the base and the nozzle between your first and second fingers. Keep your head straight, insert the nozzle into your nostril, and press down firmly on the rim while sniffing deeply. After using, wipe the nozzle clean and secure the cap.

What to Avoid

It's important to use this medication responsibly to avoid potential risks. You should never use it for more than three days, as doing so can lead to a worsening of nasal congestion. Always follow the directions provided and do not exceed the recommended dosage.

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. Remember, using more than directed or for an extended period can lead to complications, so please use it as instructed.

Side Effects

You should be aware that there are no specific side effects listed for this medication. However, if your symptoms persist while using it, it's important to stop and consult your doctor.

Before starting this medication, you should talk to 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. This will help ensure that the medication is safe for you.

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. It’s essential to keep an open line of communication with your healthcare provider to ensure you’re receiving the best care possible.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual 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 always better to err on the side of caution when it comes to your health. Remember, timely intervention can make a significant difference.

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 old, you should consult a doctor before using this medication. Always prioritize safety and follow these guidelines to ensure the well-being of your child.

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 know that your medication dosage may need to be adjusted. This is because renal impairment can affect how your body processes certain drugs. Your healthcare provider will monitor your kidney function regularly, especially by checking your creatinine clearance levels (a measure of how well your kidneys are filtering waste).

Before starting any new treatment, your renal function should be tested, and these tests will continue periodically to ensure your safety. If you have severe renal impairment, your doctor will take extra care in managing your treatment plan. Always communicate openly with your healthcare team about your kidney health to ensure the best outcomes.

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.

Your healthcare provider will likely monitor your liver function tests (which are blood tests that check how well your liver is working) to keep an eye on your liver health while you are taking the medication. Special precautions will be taken when administering the drug to ensure your safety, so be sure to discuss any concerns with your doctor.

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 way, you can work together to ensure your treatment is safe and effective.

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 guidelines will help you use the product safely and effectively.

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 dose 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 0.05% used for?

Oxymetazoline Hydrochloride 0.05% is a nasal decongestant that temporarily relieves nasal congestion due to the common cold, hay fever, and upper respiratory allergies.

How should I use Oxymetazoline Hydrochloride?

Shake well before use. 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.

Are there any precautions I should take?

Do not use more than directed or for more than 3 days, as frequent use may worsen nasal congestion. If symptoms persist, consult a doctor.

Can I use this medication if I am pregnant or breastfeeding?

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

What should I do if I accidentally swallow Oxymetazoline Hydrochloride?

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

What are the possible side effects?

Temporary discomfort such as burning, stinging, sneezing, or increased nasal discharge may occur, but no specific side effects are listed.

Who should avoid using Oxymetazoline Hydrochloride?

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 should I store Oxymetazoline Hydrochloride?

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

Packaging configurations for Signature Care Nasal Decongestant.
Details

Drug Information (PDF)

This file contains official product information for Signature Care Nasal Decongestant, 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 severe congestion associated with colds and allergies. This product is presented in a 1 FL OZ (30 mL) pump mist dosage form, designed for ease of use. The formulation includes maximum strength oxymetazoline, enhanced with menthol for additional comfort. The mist is engineered to minimize dripping from the nose or down the throat, ensuring effective delivery of the active ingredient.

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 mentioned in the available data.

Dosage and Administration

Adults and children aged 6 to under 12 years, under adult supervision, 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 physician is recommended prior to use.

Prior to administration, the product must be shaken well. To prepare the device for use, hold the white tabs, squeeze the grooved area of the cap firmly, and turn it counterclockwise. Before the initial use, the metered pump should be primed by firmly depressing the pump several times.

For application, the bottle should be held with the thumb at the base and the nozzle positioned between the first and second fingers. The nozzle should be inserted into the nostril without tilting the head. A firm, even stroke should be used to fully depress the rim while simultaneously sniffing deeply. After use, the nozzle should be wiped clean, and the cap should be securely replaced.

Contraindications

Use is contraindicated in the following situations:

  • Do not exceed the recommended dosage or duration of use (more than 3 days). Frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

  • The product should not be used by multiple individuals from the same container, as this may facilitate the spread of infection.

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 without delay.

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 aware that there are no specific side effects listed for this medication. However, it is important to monitor for any symptoms that may persist, as individuals are advised to stop use and consult a doctor if such symptoms occur.

Before using this medication, patients with certain pre-existing conditions should seek medical advice. These conditions include heart disease, high blood pressure, thyroid disease, diabetes, and difficulties urinating due to an enlarged prostate gland.

There are no additional adverse reactions 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 dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Signature Care Nasal Decongestant.
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, given the lack of targeted clinical data in 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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 may require dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to monitor renal function regularly in these patients. Adjustments in dosage should be guided by creatinine clearance levels, with particular attention given to those with severe renal impairment. Prior to initiating therapy, renal function tests should be conducted, and ongoing assessments should be performed periodically to ensure appropriate management of the patient's condition.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating dosage adjustments to ensure safety and efficacy. It is essential to monitor liver function tests in this population to assess the degree of impairment and guide treatment decisions. Special precautions should be taken when administering the drug to patients with liver problems, as their compromised liver function may increase the risk of adverse effects or alter the pharmacokinetics of the medication.

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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may also be beneficial in guiding the management of the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective 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.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

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 use. Additionally, it has been reported that the use of this container by more than one person may facilitate the spread of infection.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center 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. Patients should be informed that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Providers should also discuss the possibility of temporary discomfort, which may include symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. It is essential to inform patients that sharing this container with others may increase the risk of spreading infection.

Additionally, 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, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. This precaution is vital 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 ensure its stability and efficacy.

Healthcare professionals are advised to retain the carton for future reference regarding the full labeling information, which may be necessary for proper usage and compliance. Special handling requirements are not specified; however, standard precautions should be taken to maintain the integrity of the product during storage and handling.

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 prior to 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 Signature Care Nasal Decongestant, 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 Signature Care Nasal Decongestant, 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.