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Pseudoephedrine hydrochloride

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This product has been discontinued

Active ingredient
Pseudoephedrine Hydrochloride 120 mg
Other brand names
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 2006
Label revision date
May 7, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Pseudoephedrine Hydrochloride 120 mg
Other brand names
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 2006
Label revision date
May 7, 2013
Manufacturer
Meijer Distribution, Inc.
Registration number
ANDA077442
NDC root
41250-204
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Pseudoephedrine Hydrochloride is a non-drowsy, maximum strength nasal decongestant available in 120 mg extended-release tablets. It is designed to temporarily relieve nasal congestion caused by common colds, hay fever, and upper respiratory allergies. By promoting nasal and sinus drainage, it helps restore freer breathing through the nose and alleviates sinus congestion and pressure.

This long-acting medication is effective for those experiencing nasal and sinus congestion due to colds and allergies, providing relief when you need it most. Each package contains 10 coated capsule-shaped tablets, making it easy to manage your symptoms throughout the day.

Uses

If you're dealing with nasal congestion from a common cold, hay fever, or upper respiratory allergies, this medication can help. It temporarily relieves nasal congestion, making it easier for you to breathe through your nose. Additionally, it promotes drainage in your nasal passages and sinuses, which can alleviate sinus congestion and pressure.

This means you can expect some relief from the discomfort associated with these conditions, allowing you to feel more comfortable and breathe more freely.

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. This means you can take a tablet in the morning and another one in the evening, but make sure to stick to this schedule for your safety.

If you have a child under 12 years old, it’s best to consult a doctor before giving them this medication. They can provide guidance on the appropriate dosage for younger children. Always follow your healthcare provider's instructions to ensure safe and effective 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 or emotional 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 prescription includes an MAOI, please consult your doctor or pharmacist.

It's also important to follow the recommended dosage and not exceed the directed amount when using this product. Misusing or abusing medications can lead to serious health issues, including 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

If you experience symptoms that do not improve within 7 days, or if you develop a fever, it's important to stop using the medication and consult a doctor. Additionally, if you feel nervous, dizzy, or have trouble sleeping, seek medical advice.

Before using this medication, talk to your doctor if you have any of the following conditions: heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate. You should also avoid this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one in the past two weeks, as this can lead to serious interactions. If you're unsure whether your medication contains an MAOI, please ask your doctor or pharmacist.

Warnings and Precautions

Before taking this product, it's important to know that you should not use it if you are currently on a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson's disease, or for two weeks after stopping such medication. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist.

You should also talk to your doctor before using this product if you have any of the following conditions: heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland. If you experience an overdose, seek emergency medical help or contact a Poison Control Center immediately. Additionally, stop using this product and call your doctor if your symptoms do not improve within seven days, if you develop a fever, or if you feel nervous, dizzy, or have trouble sleeping.

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 not typical for you.

Always take overdosing seriously, as it can lead to severe health issues. If you notice any concerning symptoms or if you are unsure, don’t hesitate to reach out for professional assistance. Your safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult with a healthcare professional before using this medication. They can provide guidance tailored to your specific situation and help you understand any potential risks. Always prioritize your health and the health of your baby 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 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

While there are no specific guidelines or recommendations for older adults regarding this medication, it's always important to approach any new treatment with caution. Since the insert does not mention any dosage adjustments or safety concerns for elderly patients, you should still consult with your healthcare provider to ensure that this medication is appropriate for your individual health needs.

If you or a loved one is an older adult, discussing any potential risks or benefits with a doctor can help ensure safe and effective use of the medication. Always prioritize open communication with your healthcare team to address any questions or concerns you may have.

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 be adjusted based on your kidney function.

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

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.

Always discuss your current medications with your healthcare provider or pharmacist to ensure your safety. If you're unsure whether your prescription includes an MAOI, don't hesitate to ask for clarification. Your health and well-being are the top priority, and open communication with your healthcare team is essential.

Storage and Handling

To ensure the best performance and safety of your product, store it in a dry place at a temperature between 59° to 77° F (15° to 25° C). It's important to keep the product protected from light to maintain its effectiveness.

When handling the product, check the packaging carefully. Do not use it if the blister units are torn, broken, or show any signs of tampering, as this could compromise safety. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 1 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period. If the patient is under 12 years old, it's important to consult a doctor for the appropriate dosage.

FAQ

What is Pseudoephedrine Hydrochloride used for?

Pseudoephedrine Hydrochloride is used to temporarily relieve nasal congestion due to common cold, hay fever, and upper respiratory allergies.

How should I take Pseudoephedrine Hydrochloride?

Adults and children 12 years and older should take 1 tablet every 12 hours, not exceeding 2 tablets in 24 hours. For children under 12 years, consult a doctor.

Are there any contraindications for using this medication?

Do not use Pseudoephedrine Hydrochloride if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one in the last 2 weeks.

What should I do if my symptoms do not improve?

Stop using the medication and consult a doctor if symptoms do not improve within 7 days or if you experience a fever.

What are the side effects of Pseudoephedrine Hydrochloride?

Possible side effects include nervousness, dizziness, or sleeplessness. If you experience these, consult a doctor.

Is it safe to use Pseudoephedrine Hydrochloride if I have certain health conditions?

Before using, ask a doctor if you have heart disease, high blood pressure, diabetes, thyroid disease, or trouble urinating due to an enlarged prostate gland.

How should I store Pseudoephedrine Hydrochloride?

Store the medication at 59° to 77° F in a dry place, protected from light, and do not use if the blister units are torn or broken.

Can I use Pseudoephedrine Hydrochloride while pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using this medication.

Packaging Info

Below are the non-prescription pack sizes of Pseudoephedrine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pseudoephedrine Hydrochloride.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Pseudoephedrine Hydrochloride 120 mg Extended-Release Tablets, USP, are long-acting nasal decongestants indicated for the relief of nasal and sinus congestion due to colds and allergies, as well as sinus pressure. Each coated capsule-shaped tablet contains 120 mg of pseudoephedrine hydrochloride and is designed for maximum strength, providing a 12-hour duration of action. The product is distributed by Meijer and is available in a package containing 10 tablets. The National Drug Code (NDC) for this formulation is 41250-204-69. This formulation is comparable to the active ingredient found in Sudafed® 12 Hour and is formulated to be non-drowsy.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, and upper respiratory allergies. It is designed to restore freer breathing through the nose and promote nasal and/or sinus drainage. Additionally, it temporarily alleviates 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 12 hours. The maximum dosage should not exceed 2 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 they are uncertain whether their prescription medication contains an MAOI.

Additionally, it is contraindicated to exceed the recommended dosage while using this product.

Warnings and Precautions

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease, should not use this product. This restriction applies during the course of MAOI treatment and for a period of two weeks following the cessation of MAOI therapy. If there is uncertainty regarding the presence of an MAOI in a prescribed medication, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Healthcare professionals should exercise caution and advise patients to seek medical guidance before using this product if they have any of the following conditions: heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland. These conditions may increase the risk of adverse effects and warrant careful consideration of the product's use.

In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay to ensure appropriate management.

Patients are advised to discontinue use and consult a healthcare provider if symptoms do not improve within seven days, if symptoms are accompanied by a fever, or if they experience feelings of nervousness, dizziness, or insomnia. These symptoms may indicate a need for reevaluation of the treatment plan.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may necessitate immediate medical attention. Patients are advised to stop use and consult a healthcare professional if symptoms do not improve within 7 days, if symptoms are accompanied by a fever, or if they experience feelings of nervousness, dizziness, or sleeplessness.

Before using this product, patients with pre-existing conditions should seek medical advice. This includes individuals with heart disease, high blood pressure, diabetes, thyroid disease, or those experiencing difficulty urinating due to an enlarged prostate gland.

Additionally, the product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients must refrain from using this product while taking an MAOI and for at least 2 weeks after discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in their prescription medication, patients should consult a doctor or pharmacist prior to use.

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 Pseudoephedrine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pseudoephedrine Hydrochloride.
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 12 hours, with a maximum of 2 tablets in a 24-hour period.

Geriatric Use

There is no specific geriatric use information provided in the prescribing information. The absence of recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients indicates that the available data does not suggest any particular modifications or considerations for this population. Healthcare providers should continue to exercise clinical judgment when prescribing this medication to geriatric patients, taking into account individual patient factors and overall health status.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

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 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 have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as there is no available data to guide dosing or monitoring in this population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. Additionally, there is no information available in the nonclinical toxicology section. Furthermore, no details have been reported in the context of animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, and sleeplessness. Cardiovascular effects such as increased blood pressure, palpitations, and tachycardia have also been noted. Gastrointestinal disturbances, including nausea and vomiting, were reported alongside dermatological reactions such as rash. Additionally, allergic reactions, including anaphylaxis, have been documented. Other unspecified reactions have also been reported in the postmarketing setting.

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 they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients who are uncertain whether their prescription medication contains an MAOI should be encouraged to consult with their doctor or pharmacist prior to using this product.

Patients should be instructed to discontinue use and consult a doctor if their symptoms do not improve within 7 days or if they experience symptoms accompanied by a fever. Additionally, they should be advised to stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness.

It is important to emphasize to patients that they must adhere to the recommended dosage and not exceed the directed amount when using this product. Healthcare providers should also encourage patients to consult a doctor before use if they have any of the following conditions: heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in tamper-evident blister units. Each blister unit should not be used if it is torn, broken, or shows any signs of tampering.

For optimal storage, the product must be kept in a dry place at a temperature range of 59° to 77° F. It is essential to protect the product from light to maintain its integrity and effectiveness.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every 12 hours, with a maximum of two tablets within a 24-hour period. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.

Drug Information (PDF)

This file contains official product information for Pseudoephedrine Hydrochloride, 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 Pseudoephedrine Hydrochloride, 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

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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.