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Nasal Decongestant Pe

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Active ingredient
Phenylephrine Hydrochloride 10 mg
Other brand names
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2005
Label revision date
August 6, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 10 mg
Other brand names
Dosage form
Tablet, Film Coated
Route
Oral
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 2005
Label revision date
August 6, 2025
Manufacturer
Cardinal Health 110, LLC. DBA Leader
Registration number
M012
NDC root
70000-0126
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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™ is a maximum strength, non-drowsy nasal decongestant that contains phenylephrine HCl (10 mg) as its active ingredient. It is designed to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies, as well as to alleviate sinus congestion and pressure.

This medication is a pseudoephedrine-free option, making it suitable for those who may need to avoid that ingredient. With LEADER™, you can find relief from uncomfortable sinus pressure and congestion, helping you feel more comfortable throughout your day.

Uses

If you're dealing with nasal congestion from a common cold, hay fever, or other upper respiratory allergies, this medication can help provide temporary relief. It works by easing the swelling in your nasal passages, making it easier for you to breathe.

Additionally, if you're experiencing sinus congestion and pressure, this medication can also help alleviate those symptoms, giving you a sense of comfort and relief. Remember, it's designed for short-term use to help you feel better when you're under the weather.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 tablet every 4 hours as needed. However, make sure not to exceed 6 tablets in a 24-hour period to avoid potential side effects.

For children under 12 years old, it’s important to consult a doctor before giving them this medication. This ensures that they receive the appropriate care and dosage tailored to their specific needs. Always follow these guidelines to use the medication safely and effectively.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, do not use it for at least two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist before using this product.

It's also important to follow the recommended dosage and not exceed it, as doing so can lead to unwanted effects. Always prioritize your safety and well-being by adhering to these guidelines.

Side Effects

If you experience nervousness, dizziness, or sleeplessness while using this product, it's important to stop using it and consult your doctor. Additionally, if your symptoms do not improve within 7 days or if you develop a fever, seek medical advice.

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications used for depression, certain psychiatric conditions, or Parkinson's disease. It's also advised to wait at least 2 weeks after stopping an MAOI before using this product. If you're unsure whether your medication contains an MAOI, please check with your doctor or pharmacist.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, certain psychiatric conditions, or Parkinson's disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

Before using this product, it's important to talk to your doctor if you have any of the following conditions: diabetes, heart disease, high blood pressure, thyroid disease, or difficulty urinating due to an enlarged prostate. If you experience an overdose, seek emergency medical help or contact a Poison Control Center immediately.

You should stop using this product and call your doctor if you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within seven days or occur with a fever.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for assistance. Quick action can make a significant difference in ensuring your safety and well-being.

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 are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. For those aged 12 and older, the recommended dosage is one tablet every four hours, but be sure not to exceed six tablets in a 24-hour period. Always follow these guidelines to ensure safe and effective use for 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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

Drug Interactions

It's important to be cautious about combining medications. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, certain psychiatric conditions, or Parkinson's disease, you should not use this product. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist for clarification.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health is a priority, and your provider can help you make informed decisions about your treatment.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, ideally around 25ºC (77ºF). It can safely be kept in a range from 15ºC to 30ºC (59ºF to 86ºF). Always check the outer package before use; do not use the product if the package is opened or if the blister is torn or broken, as this indicates it may have been tampered with.

Additionally, make sure to look for the expiration date and lot number on the end flap of the package to confirm its validity. Following these guidelines will help you use the product safely and effectively.

Additional Information

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. Additionally, make sure to keep it out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center immediately.

FAQ

What is LEADER™ used for?

LEADER™ is used to temporarily relieve nasal congestion due to the common cold, hay fever, or other upper respiratory allergies, as well as sinus congestion and pressure.

What is the active ingredient in LEADER™?

The active ingredient in LEADER™ is Phenylephrine HCl, 10 mg, which acts as a nasal decongestant.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 1 tablet every 4 hours, not exceeding 6 tablets in 24 hours.

Are there any contraindications for using LEADER™?

Do not use LEADER™ if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if I experience side effects?

Stop using LEADER™ and ask a doctor if you experience nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days or occur with fever.

Is LEADER™ safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using LEADER™.

How should LEADER™ be stored?

Store LEADER™ at 25ºC (77ºF), with permitted excursions between 15º-30ºC (59º-86ºF).

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

What is the guarantee offered with LEADER™?

LEADER™ comes with a 100% money-back guarantee.

Where can I find more information about LEADER™?

You can find more information on the website www.myleader.com.

Packaging Info

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

Packaging configurations for Nasal Decongestant Pe.
Details

Drug Information (PDF)

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

View product document (PDF)

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies. Additionally, it provides temporary relief from sinus congestion and pressure.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 tablet every 4 hours as needed. The maximum recommended dosage is 6 tablets within a 24-hour period.

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

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI. Additionally, exceeding the recommended dosage is contraindicated.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

General Precautions Prior to using this product, patients should seek medical advice if they have any of the following conditions: diabetes, heart disease, high blood pressure, thyroid disease, or difficulty urinating due to prostate gland enlargement. These conditions may necessitate careful consideration and monitoring during treatment.

Emergency Medical Help In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center without delay.

Discontinuation and Consultation Patients are advised to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, medical advice should be sought promptly.

Side Effects

Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, medical advice should be sought.

It is contraindicated to use this product in conjunction with a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Furthermore, this product should not be used for 2 weeks following the cessation of an MAOI. Patients uncertain about whether their prescription includes an MAOI are advised to consult a doctor or pharmacist prior to using this product.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson's disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription medication contains an MAOI before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Nasal Decongestant Pe.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 hours, with a maximum of 6 tablets within a 24-hour period.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 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 on 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as there is no available data to guide appropriate dosing or monitoring in this population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to ensure appropriate interventions are implemented in a timely manner.

Nonclinical Toxicology

There are no teratogenic effects observed in the nonclinical studies conducted. Additionally, no non-teratogenic effects have been reported. The available data does not include specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should also be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult with their doctor or pharmacist.

Patients should be instructed to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and seek medical advice if their symptoms do not improve within seven days or if they experience symptoms accompanied by fever.

It is important to emphasize to patients the necessity of adhering to the recommended dosage and not exceeding it. Healthcare providers should also recommend that patients consult with a doctor prior to use if they have any of the following conditions: diabetes, heart disease, high blood pressure, thyroid disease, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). Healthcare professionals are advised to check the end flap of the package for the expiration date and lot number to ensure product integrity and safety.

Additional Clinical Information

Patients should be advised to consult a healthcare professional if they are pregnant or breastfeeding before using the medication. It is important to keep the product out of reach of children, and in the event of an overdose, medical assistance should be sought immediately or contact a Poison Control Center.

Drug Information (PDF)

This file contains official product information for Nasal Decongestant Pe, 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 Nasal Decongestant Pe, 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.