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Pseudoephedrine hydrochloride

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Active ingredient
Pseudoephedrine Hydrochloride 120 mg
Other brand names
Drug class
alpha-Adrenergic Agonist
Dosage form
Tablet, 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 2019
Label revision date
May 29, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Pseudoephedrine Hydrochloride 120 mg
Other brand names
Drug class
alpha-Adrenergic Agonist
Dosage form
Tablet, 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 2019
Label revision date
May 29, 2019
Manufacturer
HEB
Registration number
ANDA077442
NDC root
37808-007
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

Pseudoephedrine Hydrochloride is a long-acting nasal decongestant available in extended-release tablets, each containing 120 mg of the 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 non-drowsy, making it a suitable option for those seeking relief without the sedative effects often associated with other treatments.

Each package contains 20 coated capsule-shaped tablets, providing maximum strength relief for sinus pressure and congestion. If you're experiencing discomfort from nasal or sinus congestion, Pseudoephedrine Hydrochloride may help you feel more comfortable.

Uses

You can use this medication to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. If you're experiencing sinus congestion and pressure, this medication can also help alleviate those symptoms. It's designed to provide you with some comfort when dealing with these common issues.

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 often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, you should 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. Do not exceed the suggested amount, as misuse can lead to serious health issues. Always prioritize your safety and well-being when using any medication.

Side Effects

You may experience some side effects while using this medication. If you notice nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within 7 days or occur with a fever, it's important to stop using the product and consult a doctor.

Additionally, you should avoid this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, or if you have taken one in the past two weeks. Before using this product, consult your doctor if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson's disease, 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.

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.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Keep it out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

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

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

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 be cautious when considering this product for children. If your child is under 12 years old, you should not use this product for them. For those aged 12 and older, the recommended dosage is one tablet every 12 hours, but make sure not to exceed two tablets in a 24-hour period. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

As you age, your body may respond differently to medications, and it's important to be aware of these changes. While there are no specific dosage adjustments needed for older adults when using this product, you may be more sensitive to side effects. This means you could experience them more intensely than younger individuals.

If you or a loved one has reduced kidney function (the ability of your kidneys to filter waste) or other health conditions, it's especially important to use caution. Always consult with your healthcare provider to ensure that this medication is safe and appropriate for your specific health needs.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your kidney function might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific condition. They can help determine the best approach based on your kidney health.

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's crucial to be aware of potential interactions when taking any medication. If you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric conditions, or Parkinson's disease, you should not take 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 your medications and any lab tests with your healthcare provider to ensure your safety and the effectiveness of your treatment. This conversation can help prevent serious interactions and ensure that you receive the best care possible.

Storage and Handling

To ensure the best quality 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 it protected from light to maintain its effectiveness.

When handling the product, be sure to check the packaging carefully. If the blister units are torn, broken, or show any signs of tampering, do not use the product, as this could compromise its safety. Always prioritize these guidelines to ensure your health and safety.

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 your child is under 12 years old, do not use this product for them. Always follow these guidelines to ensure safe and effective use.

FAQ

What is Pseudoephedrine Hydrochloride used for?

Pseudoephedrine Hydrochloride 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.

How should I take Pseudoephedrine Hydrochloride?

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.

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 within the last 2 weeks.

What should I do if I experience side effects?

Stop using the medication 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.

Can I use Pseudoephedrine Hydrochloride if I have certain health conditions?

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

Is it safe to use Pseudoephedrine Hydrochloride during pregnancy or breastfeeding?

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

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

How should I store Pseudoephedrine Hydrochloride?

Store the medication at 59° to 77° F in a dry place and protect it from light. Do not use if the blister units are torn, broken, or show any signs of tampering.

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 is presented in the form of Extended-Release Tablets USP, each containing 120 mg of the active ingredient. The product is supplied as a package of 20 coated, capsule-shaped tablets. Pseudoephedrine Hydrochloride functions as a long-acting nasal decongestant and is formulated to provide non-drowsy relief.

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 dosage should not exceed 2 tablets within a 24-hour period.

This product is contraindicated 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 a period of 2 weeks following the discontinuation of an MAOI.

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

Warnings and Precautions

Use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it 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 they are uncertain whether their prescription medication contains an MAOI.

Prior to using 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.

It is imperative that patients adhere to the recommended dosage and not exceed it. Should any of the following occur, patients are advised to discontinue use and consult a healthcare professional: nervousness, dizziness, sleeplessness, or if symptoms do not improve within seven days or are accompanied by a fever.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before use.

This product should be kept out of reach of children. 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.

Side Effects

Patients may experience a range of adverse reactions while using this product. Serious adverse reactions warrant immediate medical attention, particularly in cases of overdose, where patients should seek help or contact a Poison Control Center at 1-800-222-1222.

Common adverse reactions include nervousness, dizziness, and 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.

Patients with certain pre-existing conditions should exercise caution. It is recommended that individuals with heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland consult a doctor before using this product.

Furthermore, patients 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. If there is uncertainty regarding the presence of an MAOI in a prescription drug, patients should seek guidance from a healthcare professional.

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 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. Caution is advised to ensure adherence to the dosing guidelines to prevent potential adverse effects.

Geriatric Use

Elderly patients may exhibit increased sensitivity to side effects associated with this product. Therefore, caution is advised when administering this medication to geriatric patients, particularly those who have reduced kidney function or other comorbidities.

While there are no specific dosage adjustments recommended for elderly patients, healthcare providers should closely monitor this population for any adverse reactions or complications that may arise due to their age-related physiological changes.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 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 the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials, and there is no available information regarding dosage adjustments, special monitoring, or precautions for this population. Therefore, the safety and efficacy of the medication in patients with compromised liver function remain undetermined. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, considering the lack of data on its use in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and, if applicable, the administration of specific antidotes. Continuous evaluation of the patient's condition is necessary to address any complications that may arise during the management of an overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has revealed reports of various adverse reactions associated with the use of pseudoephedrine hydrochloride. These reactions include nervousness, dizziness, and sleeplessness. Additionally, increased blood pressure, palpitations, tachycardia, and arrhythmias have been noted. Neuropsychiatric events such as hallucinations and seizures have also been reported. Dermatological reactions, including skin rash and allergic reactions, with some cases of anaphylaxis, have been documented. Other reported events include urinary retention and gastrointestinal disturbances. The frequency of these adverse reactions is not known, as they were reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to 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. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

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

It is important to remind patients not to exceed the recommended dosage while using this product. Providers should also recommend that patients 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 blister packaging, with specific NDC numbers available for identification. It is essential to store the product in a dry place at a temperature range of 59° to 77° F. Care should be taken to protect the product from light exposure to maintain its integrity.

Additionally, the packaging is designed to be tamper evident. Users are advised not to use the product if any blister units are torn, broken, or exhibit signs of tampering, ensuring safety and efficacy.

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 in a 24-hour period. It is contraindicated for use in children under 12 years of age. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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.