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Nasal Decongestant

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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 2018
Label revision date
May 4, 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 2018
Label revision date
May 4, 2025
Manufacturer
Meijer Distribution Inc
Registration number
ANDA075153
NDC root
41250-809
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

Pseudoephedrine hydrochloride extended-release tablets are a nasal decongestant designed to provide temporary relief from nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. They also help alleviate sinus congestion and pressure, making it easier for you to breathe comfortably.

These tablets are formulated to last for up to 12 hours and are non-drowsy, allowing you to go about your day without feeling sleepy. Each tablet is capsule-shaped and comes in a maximum strength dosage, ensuring effective relief when you need it most.

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, these effects are temporary, so it's important to follow the recommended guidelines for use.

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 are medications often prescribed for depression, psychiatric conditions, or Parkinson’s disease. Additionally, do not use this product 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.

It's also important to follow the recommended dosage carefully. Exceeding the suggested amount can lead to serious issues, including the potential for misuse or dependence (a condition where your body becomes reliant on a substance). Always prioritize your safety and well-being by adhering to these guidelines.

Side Effects

You may experience some side effects while using this medication, including nervousness, dizziness, or sleeplessness. If these symptoms occur, or if your symptoms do not improve within 7 days or are accompanied by a fever, it’s important to stop using the medication and consult your doctor.

Before starting this medication, you should talk to your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Warnings and Precautions

If you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson’s disease, do not use this product. You should also wait at least two weeks after stopping an MAOI before using it. If you’re unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

It's important to stop using this product and contact your doctor if you experience nervousness, dizziness, or sleeplessness. Additionally, if your symptoms do not improve within seven days or if they occur alongside a fever, reach out to your healthcare provider.

In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your safety is a priority, so please take these precautions seriously.

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

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 follow these guidelines to ensure the safety and well-being of your child.

Geriatric Use

If you are an older adult or caring for one, it's important to consult with a doctor before using this product, especially if there are existing health concerns such as heart disease, high blood pressure, thyroid issues, diabetes, or difficulties with urination due to an enlarged prostate. These conditions can affect how the medication works and may require special attention.

Additionally, this product is not recommended for children under 12 years of age. Always prioritize safety and seek professional advice to ensure the best outcomes for your health.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Your healthcare provider will monitor your kidney function regularly, especially through tests that measure creatinine clearance (a way to assess how well your kidneys are filtering waste). If you have moderate to severe renal impairment, you might require a lower dose of your medication.

Before starting any treatment, your renal function should be tested, and these tests will continue periodically to ensure your safety and the effectiveness of the therapy. Always communicate with your healthcare team about your kidney health to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. This means that your doctor might change how much of the drug you take to ensure it's safe and effective for you. Additionally, special monitoring of liver function tests (which check how well your liver is working) is recommended to keep an eye on your health.

Always exercise caution when taking this medication if you have liver dysfunction. Make sure to discuss your liver condition with your healthcare provider, as they will guide you on the best approach to manage your treatment safely.

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 is a priority, and your provider can help you make informed decisions about your treatment options.

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 using, always check the blister unit; do not use it if the unit is broken or torn, as this could compromise safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Pseudoephedrine Hydrochloride Extended-Release Tablets used for?

It is a nasal decongestant that temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies, as well as sinus congestion and pressure.

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

You should take 1 tablet every 12 hours, and do not exceed 2 tablets in 24 hours.

Can children under 12 use this product?

No, this product should not be used in children under 12 years of age.

What should I do if I experience nervousness, dizziness, or sleeplessness?

You should stop using the product and ask a doctor if these symptoms occur.

Are there any contraindications for using this medication?

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

What precautions should I take if I have certain health conditions?

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 in case of an overdose?

Get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Is it safe to use this medication during pregnancy or breastfeeding?

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

How should I store Pseudoephedrine Hydrochloride Extended-Release Tablets?

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

Packaging configurations for Nasal Decongestant.
Details

Drug Information (PDF)

This file contains official product information for 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, designed in a capsule shape for ease of administration.

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 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), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage while using this product is also contraindicated.

Warnings and Precautions

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

Patients are advised against using this product concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this product should not be used for a minimum of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional, such as a doctor or pharmacist, is strongly recommended.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within seven days or are accompanied by a fever, patients should also contact their healthcare provider for further evaluation.

In cases of overdose, it is imperative to obtain emergency medical help or contact the Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients may experience a range of adverse reactions while using this medication. Commonly reported reactions include nervousness, dizziness, and sleeplessness. These symptoms warrant immediate attention; patients should stop use and consult a healthcare professional if they experience any of these reactions. Additionally, if symptoms do not improve within 7 days or are accompanied by a fever, patients are advised to seek medical advice.

It is important for patients to inform their healthcare provider before using this medication if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. These pre-existing conditions may influence the safety and efficacy of the treatment.

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 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 includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for 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 should consult a healthcare provider prior to using this product, particularly if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties related to an enlarged prostate gland.

Additionally, this product is not indicated for use in children under 12 years of age. Caution is advised when prescribing to geriatric patients, and careful monitoring may be necessary to ensure safety and efficacy 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 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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels, with reduced doses potentially required for those with moderate to severe renal impairment. Additionally, renal function tests should be performed prior to initiating therapy and periodically thereafter to ensure appropriate management of the patient's condition.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is essential to monitor liver function tests closely in this population to ensure safety and efficacy. Caution should be exercised when administering the drug to patients with liver dysfunction, as their altered metabolic capacity may affect drug clearance and overall treatment outcomes.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective treatment and follow-up care.

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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 their doctor or pharmacist prior to use.

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.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and not exceeding it while using this product. It is also essential to encourage patients to consult a doctor before 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. It is essential to protect the product from light exposure. Additionally, the product must not be used if the blister unit is broken or torn, as this may compromise its integrity and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 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 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.