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Extra Strength Sinus Relief Nasal Decongestant

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Active ingredient
Phenylephrine Hydrochloride 1 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 2017
Label revision date
November 21, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 1 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 2017
Label revision date
November 21, 2024
Manufacturer
CARDINAL HEALTH
Registration number
M012
NDC root
70000-0132
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

LEADER Extra Strength Sinus Relief is a nasal decongestant that contains phenylephrine hydrochloride (1.0%), which helps to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. This medication works by shrinking swollen membranes in your nasal passages, allowing for easier breathing and helping to clear sinus openings and relieve pressure.

You can use this product to alleviate a stuffy nose and restore freer breathing through the nose, making it a helpful option when you're feeling congested.

Uses

If you're dealing with nasal congestion, this medication can help provide temporary relief. It works effectively for congestion caused by the common cold, hay fever, or other upper respiratory allergies (also known as allergic rhinitis).

By helping to clear your nasal passages and shrinking swollen membranes, this medication allows for easier breathing through your nose. It also targets sinus openings and passages, relieving sinus congestion and pressure, so you can feel more comfortable.

Dosage and Administration

When using this medication, it's important to follow the directions provided. To apply the spray, you should squeeze the bottle quickly and firmly. For adults and children aged 12 years and older, you can use 2 or 3 sprays in each nostril, but make sure not to do this more often than every 4 hours.

If the user is a child under 12 years old, it's best to consult a doctor before use to ensure safety and proper dosage. Always remember to use the medication only as directed for the best results.

What to Avoid

You should avoid using this product if you have ever had an allergic reaction to it or any of its ingredients. It's important to follow the recommended dosage and not exceed it, as well as to limit your use to no more than three days. Always use the product as directed.

If your symptoms last longer than three days, you should stop using the product and consult a doctor. Remember, taking medications responsibly is crucial to prevent issues like dependence (a condition where your body becomes reliant on a substance) and to avoid misuse or abuse.

Side Effects

If you have ever had an allergic reaction to this product or any of its ingredients, you should not use it. It's important to stop using the product and consult a doctor if your symptoms last longer than three days.

Before using this product, talk to your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland. These conditions may affect how the product works for you.

Warnings and Precautions

You should avoid using this product if you have ever had an allergic reaction to it or any of its ingredients. Before starting, 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.

If you accidentally swallow the product, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Additionally, if your symptoms last longer than three days, stop using the product and reach out to your doctor for further advice.

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 unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, 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

If you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is 2 or 3 sprays in each nostril, but this should not be done more frequently than every 4 hours. Always follow these guidelines to ensure the safety and well-being of your child.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 is safe and effective, especially if you have concerns about your kidney health. They can provide guidance based on your individual situation.

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 detailed guidelines available regarding how the medication may affect you or how your liver health might influence the medication's effectiveness or safety.

Before starting any new medication, it's crucial to discuss your liver condition with your healthcare provider. They can help determine the best approach for your treatment and ensure that you are monitored appropriately. Always keep your doctor informed about your liver health to receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medication or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, away from direct sunlight. It's important to protect it from light exposure, as this can affect its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should use this medication as directed, administering it nasally. For adults and children aged 12 and older, the recommended dose is 2 or 3 sprays in each nostril, but not more often than every 4 hours. If the patient is under 12 years old, consult a doctor for guidance.

Be aware that some temporary discomfort may occur, including burning, stinging, sneezing, or an increase in nasal discharge. It's important to avoid sharing the container with others, as this can spread infection. Always follow the instructions provided for safe and effective use.

FAQ

What is LEADER Extra Strength Sinus Relief used for?

LEADER Extra Strength Sinus Relief is a nasal decongestant that temporarily relieves nasal congestion due to the common cold, hay fever, and other upper respiratory allergies.

How should I use LEADER Extra Strength Sinus Relief?

For adults and children 12 years and older, use 2 or 3 sprays in each nostril not more often than every 4 hours. Children under 12 years should ask a doctor before use.

Are there any important warnings for this product?

Do not use if you have ever had an allergic reaction to this product or any of its ingredients. If symptoms persist for more than 3 days, stop use and ask a doctor.

What should I do if I accidentally swallow this product?

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

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

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

What are the possible side effects of using this product?

Temporary discomfort may occur, such as burning, stinging, sneezing, and an increase in nasal discharge.

How should I store LEADER Extra Strength Sinus Relief?

Store at room temperature and protect from light.

Packaging Info

Below are the non-prescription pack sizes of Extra Strength Sinus Relief Nasal Decongestant (phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Sinus Relief Nasal Decongestant.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

LEADER Extra Strength Sinus Relief contains phenylephrine hydrochloride as its active ingredient at a concentration of 1.0%. This formulation serves as a nasal decongestant, providing fast relief from sinus congestion and pressure associated with colds and allergies. The product is available in a package size of 1 fluid ounce (30 mL) and is identified by the National Drug Code (NDC) 70000-0132-1.

This product is comparable to the active ingredient found in NEO-SYNEPHRINE® Extra Strength. It is distributed by Cardinal Health, located in Dublin, Ohio 43017. For further information, the manufacturer's website is www.myleader.com, and customer service can be reached at 1-800-200-6313. Cardinal Health™, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, and other upper respiratory allergies (allergic rhinitis). It provides symptomatic relief by temporarily alleviating a stuffy nose, helping to clear nasal passages, and shrinking swollen membranes. Additionally, this drug aids in restoring freer breathing through the nose and decongests sinus openings and passages, thereby temporarily relieving sinus congestion and pressure.

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

Dosage and Administration

The medication should be used only as directed. For administration, the user should squeeze the bottle quickly and firmly to deliver the spray.

For adults and children aged 12 years and older, the recommended dosage is 2 to 3 sprays in each nostril, not to be administered more frequently than every 4 hours.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in individuals with a history of allergic reactions to this product or any of its ingredients. Due to the potential for adverse effects, it is essential to adhere to the recommended dosage and duration of use, which should not exceed three days. If symptoms persist beyond this period, consultation with a healthcare professional is advised.

Warnings and Precautions

Patients with a history of allergic reactions to this product or any of its ingredients should not use it.

Healthcare professionals are advised to exercise caution and recommend that patients 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 or complications associated with the product.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay.

If symptoms persist beyond three days, patients are instructed to discontinue use and consult their healthcare provider for further evaluation and management.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. It is contraindicated in individuals who have a history of allergic reactions to this product or any of its ingredients.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if symptoms persist for more than three days. Additionally, it is recommended that patients seek medical advice prior to 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.

These precautions are essential to ensure the safe use of the product and to mitigate the risk of adverse reactions in susceptible individuals.

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 Extra Strength Sinus Relief Nasal Decongestant (phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Sinus Relief Nasal Decongestant.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before using this medication. For adolescents and adults aged 12 years and older, the recommended dosage is 2 or 3 sprays in each nostril, not to be administered more frequently than every 4 hours.

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.

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 the safety of both the mother and the developing fetus.

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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include airway management, monitoring of vital signs, and intravenous fluid administration as necessary. The use of specific antidotes should be considered based on the clinical scenario and the substance involved, if applicable.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on the management of overdose cases. Documentation of the incident and any interventions performed should be meticulously recorded in the patient's medical record to ensure continuity of care and facilitate further treatment if required.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that temporary discomfort may occur following use, including symptoms such as burning, stinging, sneezing, and an increase in nasal discharge. 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 keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed not to use the product if they have ever experienced an allergic reaction to it or any of its ingredients. It is important to instruct patients to stop using the product and consult a doctor if symptoms persist for more than three days.

When using this product, patients must be cautioned not to exceed the recommended dosage and to limit use to no more than three days, adhering strictly to the directions provided. They should be made aware that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. Patients may experience temporary discomfort, which can include burning, stinging, sneezing, and an increase in nasal discharge. Additionally, it should be emphasized that the use of this container by more than one person may facilitate the spread of infection.

Healthcare providers should also encourage patients to consult a doctor before using this product if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, or difficulty in urination due to prostate enlargement.

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 to maintain its integrity and efficacy. Additionally, the product must be protected from light to prevent degradation. Proper handling and storage conditions are crucial to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

The medication is administered via the nasal route. For adults and children aged 12 years and older, the recommended dosage is 2 or 3 sprays in each nostril, not to be used more frequently than every 4 hours. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Patients may experience temporary discomfort, including burning, stinging, sneezing, and an increase in nasal discharge. Clinicians should counsel patients on the importance of using the medication as directed and inform them that sharing the container with others may lead to the spread of infection.

Drug Information (PDF)

This file contains official product information for Extra Strength Sinus Relief 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 Extra Strength Sinus Relief 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.

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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.