Symptom checker
Select audience type

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

ADD CONDITION

items per page

Pseudoephedrine hydrochloride

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, 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 2017
Label revision date
November 3, 2022
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 2017
Label revision date
November 3, 2022
Manufacturer
Aurohealth LLC
Registration number
ANDA209008
NDC root
58602-804
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 HCl is a long-acting nasal decongestant that comes in extended-release tablet form, with each tablet 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.

These coated caplets are non-drowsy and provide relief for up to 12 hours, making them a convenient option for managing symptoms throughout the day. If you're experiencing nasal or sinus congestion, Pseudoephedrine HCl may help you breathe more easily.

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 or emotional conditions, or Parkinson’s disease. Additionally, do not use this product for at least two weeks after stopping an MAOI. If you are unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist before using this product.

It's also important to follow the recommended dosage carefully. Exceeding the suggested amount can lead to serious issues, including potential 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 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, consult 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 with a fever, reach out to your healthcare provider for guidance.

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 there is no specific information available about the signs of overdose for this medication, general 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

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. You should not use it for anyone 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 safety and effectiveness.

Geriatric Use

When it comes to using this medication in older adults, there are no specific guidelines or recommendations regarding age-related dosage adjustments or safety concerns. This means that while the medication can be prescribed to older patients, healthcare providers may not have tailored information to guide them in making decisions about your treatment.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks or concerns with your healthcare provider. They can help ensure that the treatment is appropriate for your individual health needs.

Renal Impairment

If you have kidney problems, it's important to know that you may need a lower dose of this medication. Your doctor will determine the right dosage based on your creatinine clearance levels, which is a test that measures how well your kidneys are filtering waste from your blood.

To ensure your kidneys remain healthy while taking this medication, regular renal function tests are recommended. If you have severe renal impairment, special monitoring is essential to prevent any potential toxicity from the medication. Always discuss your kidney health with your healthcare provider to ensure safe and effective treatment.

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 are blood tests that check how well your liver is working) is recommended to keep an eye on your liver health while you are on this medication.

Always exercise caution when taking this drug 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 crucial to be aware of potential interactions when taking medications. 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 need to 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 harmful interactions. Your health is important, and your provider can help you make informed decisions about your treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). It's important to keep it protected from light to maintain its effectiveness.

When handling the product, be cautious not to use it if the individual blister unit is open or torn, as this could compromise safety and effectiveness. Always check the packaging before use to ensure it is intact.

Additional Information

You should take this medication orally. For adults and children 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. If your child is under 12 years old, do not use this product for them. Always follow the dosage instructions to ensure safe and effective use.

FAQ

What is Pseudoephedrine HCl?

Pseudoephedrine HCl is a long-acting nasal decongestant available in extended-release tablets of 120 mg.

What does Pseudoephedrine HCl do?

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

How should adults and children 12 years and over take Pseudoephedrine HCl?

You should take 1 tablet every 12 hours, not exceeding 2 tablets in 24 hours.

Can children under 12 years use Pseudoephedrine HCl?

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

Are there any contraindications for using Pseudoephedrine HCl?

Do not use this product 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 nervousness or dizziness while taking Pseudoephedrine HCl?

Stop using the medication and consult your doctor if you experience nervousness, dizziness, or sleeplessness.

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.

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

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

How should Pseudoephedrine HCl be stored?

Store the medication at 20° to 25°C (68° to 77°F) and protect it from light.

Packaging Info

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

Packaging configurations for Pseudoephedrine Hcl.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

AUROHEALTH is a maximum strength, long-acting nasal decongestant formulated as extended-release tablets. Each tablet contains 120 mg of pseudoephedrine hydrochloride, the active ingredient comparable to that found in Sudafed® 12 Hour. The product is presented in a capsule-shaped form, with a total of 20 coated caplets per package. This formulation is designed to relieve sinus pressure and congestion for up to 12 hours without causing drowsiness. The National Drug Code (NDC) for this product is 58602-804-67.

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 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 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 should exercise caution and refrain from using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this product should not be used for at least two weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise 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 consult their doctor.

No specific laboratory tests are recommended for monitoring in relation to the use of this product.

Side Effects

Patients may experience a range of adverse reactions while using this medication. Commonly reported symptoms include nervousness, dizziness, and sleeplessness. It is important for patients to monitor their symptoms closely; if these symptoms do not improve within 7 days or are accompanied by a fever, they should seek medical attention.

Additionally, patients with pre-existing conditions should consult a healthcare professional before using this medication. This includes individuals with heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland.

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 includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Pseudoephedrine Hcl.
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 overdose.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 therapeutic response, given the lack of targeted data for this population. Individualized assessment and clinical judgment are essential when determining the appropriateness of treatment in elderly patients.

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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment may require a reduced dose of the medication. Dosage adjustments should be based on creatinine clearance levels to ensure appropriate therapeutic levels while minimizing the risk of adverse effects. Regular renal function tests are recommended to monitor kidney health in patients receiving this medication. Additionally, special monitoring is necessary for patients with severe renal impairment to avoid potential toxicity.

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 patients closely for any signs or symptoms that may arise following 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

For further guidance, healthcare professionals are encouraged to consult local poison control centers or relevant clinical guidelines to determine the most appropriate management strategies tailored to the specific circumstances of the overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. In the event of experiencing nervousness, dizziness, or sleeplessness, it is recommended to discontinue use and seek medical advice. Additionally, if symptoms do not improve within seven days or are accompanied by a fever, medical consultation should be sought.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, and sleeplessness. Additionally, reports have noted symptoms that do not improve within 7 days or occur in conjunction with a fever.

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 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 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 while using this product. Healthcare providers should also encourage patients to consult with 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 individual blister units. Each unit must be stored at a temperature range of 20° to 25°C (68° to 77°F) and should be protected from light to maintain its integrity. It is imperative that the product is not used if the individual blister unit is open or torn, as this may compromise the quality and safety of the medication.

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. It is contraindicated for use in children under 12 years of age. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Pseudoephedrine Hcl, 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 Hcl, 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.