Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Leader 12 Hour Sinus Nasal Decongestant

Last content change checked dailysee data sync status

Active ingredient
Pseudoephedrine Hydrochloride 120 mg
Other brand names
Drug class
alpha-Adrenergic Agonist
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
August 7, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Pseudoephedrine Hydrochloride 120 mg
Other brand names
Drug class
alpha-Adrenergic Agonist
Dosage form
Tablet, Film Coated, Extended Release
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 2025
Label revision date
August 7, 2025
Manufacturer
Cardinal Health 110, LLC. dba Leader
Registration number
ANDA075153
NDC root
70000-0735
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™ is a maximum strength, non-drowsy nasal decongestant that comes in the form of extended-release tablets containing 120 mg of pseudoephedrine hydrochloride. It is designed to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies, as well as alleviate sinus congestion and pressure.

This medication works by targeting the underlying causes of congestion, helping you breathe more easily and feel more comfortable. With its 12-hour effectiveness, LEADER™ can provide you with lasting relief throughout your day.

Uses

If you're dealing with a stuffy nose from a common cold, hay fever, or other upper respiratory allergies, this medication can help. It works by temporarily relieving nasal congestion, making it easier for you to breathe.

Additionally, if you're experiencing sinus congestion and pressure, this medication can provide temporary relief, helping to ease discomfort in your sinuses.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 tablet every 12 hours. It's important not to exceed 2 tablets in a 24-hour period to ensure your safety and avoid potential side effects.

For children under 12 years of age, this product is not recommended, so please do not use it for younger children. Always follow these guidelines to ensure effective and safe use of the medication.

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 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 medication contains 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. Taking more than the advised amount can lead to serious health risks. Always prioritize your safety and well-being by adhering to these guidelines.

Side Effects

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

Before using this medication, 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. Also, do not use this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain psychiatric conditions, or if you have stopped taking an MAOI within the last two weeks.

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 or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. 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: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. Always follow the recommended dosage and do not exceed it.

If you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within 7 days or occur with a fever, stop using the product and contact your doctor. In case of an overdose, seek medical help immediately or call a Poison Control Center at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Acting quickly is important, so don’t hesitate to reach out for assistance if you notice any of these symptoms or if you believe you or someone else has taken too much of the medication. Your safety is the top priority, and professional help can provide the necessary support and treatment.

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

It's important to know that this product should not be given to children under 12 years of age. For those who are 12 years and older, the recommended dosage is one tablet every 12 hours, with a maximum of two tablets in a 24-hour period. Always ensure you follow these guidelines to keep your child safe and healthy.

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 before starting the medication. 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 consult your doctor before using this medication, especially if you experience difficulty urinating due to an enlarged prostate gland. Your healthcare provider can help determine if this medication is safe for you and may suggest adjustments to your dosage or monitoring based on your kidney function. Always prioritize open communication with your doctor regarding any concerns related to 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 should be used if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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, 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 and well-being are the top priority, so don't hesitate to ask questions about your treatments.

Storage and Handling

To ensure the best performance of your product, store it in a dry place at a temperature between 20-25°C (68-77°F). It's important to keep it protected from light to maintain its effectiveness. Before use, check the blister unit carefully; do not use it if the unit is broken or torn, as this could compromise safety. Additionally, you can find the lot number and expiration date on the end panel of the carton, so be sure to check these details before using the product.

Additional Information

You should take this medication orally, with one tablet every 12 hours. It's important not to exceed two tablets within a 24-hour period to ensure your safety and the effectiveness of the treatment. If you have any questions or concerns about your medication, be sure to consult with your healthcare provider.

FAQ

What is LEADER™?

LEADER™ is a maximum strength, non-drowsy nasal decongestant that temporarily relieves sinus pressure and congestion due to the common cold, hay fever, or other upper respiratory allergies.

How should I take LEADER™?

Adults and children 12 years and over should take 1 tablet every 12 hours, not exceeding 2 tablets in 24 hours. Do not use this product in children under 12 years of age.

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 a fever.

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. Consult a doctor or pharmacist if unsure.

What should I do if I am pregnant or breastfeeding?

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

How should I store LEADER™?

Store LEADER™ at 20-25°C (68-77°F) in a dry place, protected from light, and do not use if the blister unit is broken or torn.

Packaging Info

Below are the non-prescription pack sizes of Leader 12 Hour Sinus Nasal Decongestant (pseudoephedrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Leader 12 Hour Sinus Nasal Decongestant.
Details

Drug Information (PDF)

This file contains official product information for Leader 12 Hour Sinus Nasal Decongestant, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Pseudoephedrine Hydrochloride Extended Release Tablets are formulated as nasal decongestants, each containing 120 mg of the active ingredient. The product is presented in a package containing 10 coated caplets, which are capsule-shaped in design.

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 of sinus congestion and pressure.

Limitations of Use: This medication is intended for short-term use and should not be used as a long-term treatment for nasal or sinus congestion.

Dosage and Administration

Adults and children 12 years and older are instructed to take 1 tablet every 12 hours. The maximum allowable dosage is 2 tablets within a 24-hour period.

This product is not recommended for use in children under 12 years of age.

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

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use of this product is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Before initiating treatment with this product, patients should seek medical advice 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.

During the use of this product, it is crucial to adhere strictly to the recommended dosage. Exceeding the recommended dosage may lead to adverse effects.

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

In the event of an overdose, immediate medical assistance should be obtained, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients may experience a range of adverse reactions while using this medication. Serious adverse reactions warrant immediate medical attention and include symptoms such as nervousness, dizziness, or sleeplessness. Patients are advised to discontinue use and consult a healthcare professional if these symptoms occur. Additionally, if symptoms do not improve within 7 days or are accompanied by a fever, medical advice should be sought.

Common adverse reactions may arise in patients with pre-existing conditions. It is recommended that individuals with heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland consult a healthcare provider before using this medication.

Furthermore, patients should not use this medication concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are used for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease. Use is contraindicated during treatment with MAOIs and for a period of 2 weeks following the cessation of MAOI therapy.

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, certain psychiatric conditions, or Parkinson’s disease. Patients should not take this product while on MAOIs or within 2 weeks of discontinuing an MAOI. It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to confirm whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Leader 12 Hour Sinus Nasal Decongestant (pseudoephedrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Leader 12 Hour Sinus Nasal Decongestant.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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 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 no specific data available regarding the excretion of this medication in 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 should consult a healthcare professional prior to use if they experience difficulty urinating due to an enlarged prostate gland. This precaution is essential to ensure appropriate management and monitoring of their condition, as reduced kidney function may influence the pharmacokinetics and safety profile of the medication.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented by the patient. Continuous assessment and monitoring of vital signs are recommended to ensure patient safety and to guide further therapeutic interventions.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of the following adverse reactions: nervousness, dizziness, and sleeplessness. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 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 a 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: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in a blister pack configuration. It should be stored at a temperature range of 20-25°C (68-77°F) in a dry place, ensuring protection from light. Healthcare professionals are advised to inspect the blister unit prior to use; the product should not be used if the blister unit is broken or torn. For tracking purposes, the lot number and expiration date can be found on the end panel of the carton.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of one tablet every 12 hours. Patients should not exceed a total of two tablets within a 24-hour period. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Leader 12 Hour Sinus 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 Leader 12 Hour Sinus 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.