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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 2017
Label revision date
August 11, 2020
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
August 11, 2020
Manufacturer
STRATEGIC SOURCING SERVICES LLC
Registration number
ANDA077442
NDC root
62011-0306
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 120 mg extended-release tablets. It is designed to provide non-drowsy relief from nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. Additionally, it helps alleviate sinus congestion and pressure, making it a useful option for those experiencing discomfort from these conditions.

This medication works for up to 12 hours, allowing you to breathe more easily throughout the day. If you're dealing with sinus pressure and congestion, Pseudoephedrine Hydrochloride may be an effective choice to help you feel more comfortable.

Uses

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

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

Dosage and Administration

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

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

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which 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 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

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

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

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

Before using this product, it's important to talk to your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. Always follow the recommended dosage and do not exceed it. If you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within seven days or occur with a fever, stop using the product and contact your doctor.

Keep this product out of reach of children. 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 know that this product should not be used in children under 12 years of age. If you have a child in this age group, please consult your healthcare provider for alternative options that are safe and appropriate for their needs. Always prioritize your child's health and safety by following these guidelines.

Geriatric Use

When it comes to using this medication in older adults, there are no specific changes to the dosage recommended. However, it's important to be aware that older adults may be more sensitive to side effects, which means they could experience them more intensely than younger individuals.

If you are caring for an older adult, especially one with reduced kidney function (the ability of the kidneys to filter waste) or other health conditions, it's crucial to approach the use of this medication with caution. Always consult with a healthcare provider to ensure safe and effective use tailored to their specific health needs.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (issues with liver function).

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

Drug Interactions

It's 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 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 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 and effectiveness. Always prioritize these guidelines to ensure your safety and the proper use of the product.

Additional Information

You should take this medication orally, with one tablet every 12 hours. It's important not to exceed two tablets in a 24-hour period. If you are pregnant or breastfeeding, consult a healthcare professional before using this medication.

Keep this medicine out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Pseudoephedrine Hydrochloride?

Pseudoephedrine Hydrochloride is a long-acting nasal decongestant available in 120 mg extended-release tablets that temporarily relieves nasal and sinus congestion.

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.

What should I do if I experience side effects?

Stop use and ask a doctor if you experience nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days or occur with a fever.

Are there any contraindications for using this medication?

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

What precautions should I take before using this medication?

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 overdose?

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Can I use this medication if I am pregnant or breastfeeding?

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

How should I store Pseudoephedrine Hydrochloride?

Store at 59° to 77° F in a dry place and protect from light. Do not use if 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 an extended-release tablet dosage form, with each tablet containing 120 mg of the active ingredient. This formulation serves as a long-acting nasal decongestant, designed to provide relief for up to 12 hours. The product is supplied in a package containing 10 coated, capsule-shaped tablets, each delivering the specified dosage of 120 mg. The formulation is characterized by its non-drowsy properties, making it suitable for use throughout the day.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies. Additionally, it provides temporary relief of sinus congestion and pressure.

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

Dosage and Administration

Adults and children 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 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

The 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 initiating treatment with this product, it is essential for patients to 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. These conditions may increase the risk of adverse effects or complications.

Patients must adhere strictly to the recommended dosage guidelines. Exceeding the recommended dosage can lead to serious health risks.

In the event that patients experience nervousness, dizziness, or sleeplessness, they should discontinue use and consult a healthcare professional. Furthermore, if symptoms do not improve within seven days or if they are accompanied by a fever, medical advice should be sought promptly.

This product should be stored out of reach of children. In the case of an overdose, immediate medical assistance should be obtained, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

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

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

Warnings are in place regarding the concurrent use of this product with prescription monoamine oxidase inhibitors (MAOIs). Patients should not use this product if they are currently taking an MAOI or have stopped taking one within the past two weeks. If there is uncertainty regarding the presence of an MAOI in their prescription medication, patients should seek clarification from a healthcare professional or pharmacist before proceeding with this product.

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. Safety and efficacy have not been established in this age group, and the potential risks may outweigh any benefits. Healthcare professionals are advised to consider alternative treatments for pediatric patients within this age range.

Geriatric Use

Elderly patients may not require specific dosage adjustments when receiving this product. However, it is important to note that this population may exhibit increased sensitivity to side effects.

Caution is advised when administering this product to geriatric patients, especially those with reduced kidney function or other comorbidities. Close monitoring for adverse effects is recommended to ensure patient safety and to manage any potential complications effectively.

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 healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. 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 effectively. 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 identify any potential adverse effects.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance involved. Continuous monitoring of vital signs and laboratory parameters may be necessary to guide further treatment decisions.

In summary, immediate medical attention and appropriate management strategies are vital in addressing overdose cases to mitigate potential complications and ensure patient safety.

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 identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, and sleeplessness. Additionally, cardiovascular and metabolic conditions such as heart disease, high blood pressure, and diabetes have been noted. Endocrine-related issues, specifically thyroid disease, have also been reported. Furthermore, instances of urinary difficulties due to an enlarged prostate gland have been documented.

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 last 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. Furthermore, patients should be encouraged 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 blister packaging, with specific attention to tamper evidence. Each blister unit must remain intact; do not use if any blister units are torn, broken, or exhibit signs of tampering.

For optimal storage, the product should 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 efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of one tablet every 12 hours, not to exceed two tablets within a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is also important to instruct patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

No additional information is available regarding laboratory tests, abuse potential, 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

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.