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Signature Care Original

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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
October 16, 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
October 16, 2025
Manufacturer
SAFEWAY, INC.
Registration number
M012
NDC root
21130-956
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

You may be looking for a medication that is used to relieve nasal congestion. This type of medication typically comes in a spray form and is designed to be used in the nostrils. It works by helping to reduce swelling in the nasal passages, making it easier for you to breathe when you have a cold, allergies, or sinus issues.

For adults and children aged 6 to under 12 years, it is usually recommended to use 2 or 3 sprays in each nostril, but not more than twice in a 24-hour period. If you have a child under 6, it's best to consult a doctor before use. Always remember to shake the bottle well before spraying and follow the instructions carefully for the best results.

Uses

This medication is used for individuals aged 6 years and older, including adults, to help relieve certain symptoms. If you are between 6 and 12 years old, you can use 2 or 3 sprays in each nostril, but make sure to do this no more than every 10 to 12 hours. It's important not to exceed 2 doses within a 24-hour period. If you have a child under 6 years old, please consult a doctor before use.

Additionally, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, and there are no reported nonteratogenic effects (which refers to effects that do not cause birth defects). Always ensure you follow the recommended guidelines for safe use.

Dosage and Administration

It seems that there are no specific dosage or administration details available for this medication. This means that you should consult your healthcare provider for personalized instructions on how to take or use it. They will provide you with the necessary information regarding the correct dosage, how to administer it, and how often you should do so. Always follow their guidance to ensure safe and effective use of the medication.

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 return or worsening of nasal congestion.

To protect yourself from potential issues, make sure to adhere strictly to the recommended usage guidelines. If you have any concerns or questions about how to use this medication, don't hesitate to reach out to your healthcare provider for guidance.

Side Effects

If you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate, it's important to consult your doctor before using this medication.

You should also stop using the medication and reach out to your doctor if your symptoms do not improve. Your health and safety are the top priority, so don't hesitate to seek professional advice if you have any concerns.

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. These conditions may affect how the medication works for you.

Keep this medication out of reach of children. If a child accidentally swallows it, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. Additionally, if your symptoms do not improve or persist, stop taking the medication and reach out to your doctor for further guidance.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency services or go to the nearest hospital. Always keep your medications in their original packaging and follow the prescribed dosage to minimize the risk of an overdose. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 your child is under 6 years old, it's important to consult a doctor before using this medication. For children aged 6 to under 12 years, you can 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 to ensure their safety. Always supervise your child during use to help them follow these guidelines properly.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

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

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no detailed recommendations available for how your liver health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and appropriate for your liver condition. They can help you understand how to manage your health effectively while considering your liver function.

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 feel free to ask questions and share your complete list of medications and any tests you are undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

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

When handling the product, be sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

The medication is administered through the nasal route. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Additionally, keep it out of reach of children. If the medication is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is the recommended dosage for adults and children aged 6 to under 12?

For adults and children aged 6 to under 12 years (with adult supervision), 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.

What should I do if my child is under 6 years old?

If your child is under 6 years of age, you should consult a doctor before use.

What are the instructions for using the spray?

Shake well before use, remove the safety seal, and follow the instructions to spray into the nostril without tilting the head. Wipe the nozzle clean after use.

Are there any warnings I should be aware of?

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.

What should I do if symptoms persist?

If symptoms persist, you should stop use and ask a doctor for advice.

What should I do in case of accidental ingestion?

Keep the product out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Is it safe to use if I am pregnant or breastfeeding?

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

How should I store the medication?

Store the medication at room temperature between 20-25°C (68-77°F).

Can I use this medication for more than 3 days?

No, do not use this medication for more than 3 days, as frequent or prolonged use may worsen nasal congestion.

Packaging Info

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

Packaging configurations for Signature Care Original.
Details

Drug Information (PDF)

This file contains official product information for Signature Care Original, 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 relief of nasal congestion in adults and children aged 6 to under 12 years, to be administered as 2 or 3 sprays in each nostril, not more frequently than every 10 to 12 hours. The maximum recommended dosage is 2 doses within a 24-hour period. For children under 6 years of age, consultation with a healthcare professional is advised prior to use.

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

Dosage and Administration

There is currently no specific dosage or administration information available for this medication. Healthcare professionals are advised to refer to the prescribing information or clinical guidelines for detailed instructions regarding the appropriate dosage, route, method, and frequency of administration. It is essential to consider individual patient factors and clinical judgment when determining the appropriate treatment regimen.

Contraindications

There are no specified contraindications for this product. However, it is essential to adhere to the following usage instructions to avoid potential complications:

  • Do not exceed the recommended dosage.

  • Do not use for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion.

Healthcare professionals should ensure that patients are informed of these guidelines to promote safe and effective use.

Warnings and Precautions

Healthcare professionals should advise patients 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.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately. Patients should be instructed to keep the product out of reach of children. If swallowed, they should contact a Poison Control Center at 1-800-222-1222 without delay.

Patients are also advised to discontinue use and consult their healthcare provider if symptoms persist. Ongoing symptoms may indicate a need for reevaluation of the treatment plan or further investigation into underlying health issues.

Side Effects

Patients should be aware of certain warnings associated with the use of this medication. It is advised to consult a healthcare professional prior to use if there is a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

In the event that symptoms persist, patients are instructed to discontinue use and seek medical advice. This precaution is essential to ensure the safety and well-being of individuals using the medication.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Signature Care Original.
Details

Pediatric Use

Pediatric patients under 6 years of age should consult a doctor prior to use. For children aged 6 to under 12 years, the recommended dosage is 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. It is important not to exceed 2 doses within a 24-hour period. Adult supervision is advised for this age group.

Geriatric Use

There is no specific information available 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 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while no specific overdosage information is provided, healthcare professionals should exercise caution and be prepared to act swiftly in the event of an overdose, ensuring that appropriate measures are taken to safeguard patient health.

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 identified several adverse reactions associated with the use of the product. Reports indicate that temporary discomfort may occur, including sensations of burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it has been noted that frequent or prolonged use of the product 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. 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 their symptoms persist. It is important to emphasize that when using this product, patients must not exceed the directed dosage and should not use it 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.

Additionally, patients should be made aware that temporary discomfort, such as burning, stinging, sneezing, or an increase in nasal discharge, may occur during use. It is also crucial to inform patients that the use of this container by more than one person may increase the risk of spreading infection.

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 room temperature, maintaining a range of 20-25°C (68-77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The product is administered via the nasal route. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is also important to instruct patients to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Signature Care 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 Signature Care 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.

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.