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Nasal Decongestant

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Active ingredient
Pseudoephedrine Hydrochloride 30 mg
Other brand names
Drug class
alpha-Adrenergic Agonist
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1981
Label revision date
July 9, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Pseudoephedrine Hydrochloride 30 mg
Other brand names
Drug class
alpha-Adrenergic Agonist
Dosage form
Tablet, Film Coated
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 1981
Label revision date
July 9, 2025
Manufacturer
CVS Pharmacy
Registration number
M012
NDC root
59779-112
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 non-drowsy nasal decongestant that helps relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. It also temporarily alleviates sinus congestion and pressure, making it easier for you to breathe.

This medication is similar to the active ingredient found in Sudafed Sinus Congestion and is available in a maximum strength of 30 mg per tablet. If you're experiencing discomfort from nasal or sinus congestion, pseudoephedrine hydrochloride may provide the relief you need.

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 both nasal and sinus congestion, as well as reducing the pressure in your sinuses.

Whether you're feeling stuffed up or experiencing sinus pressure, this treatment is designed to help you breathe easier and feel more comfortable.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 2 tablets every 4 to 6 hours as needed. However, make sure not to exceed 8 tablets in a 24-hour period to avoid potential side effects.

For children between the ages of 6 and 11 years, the recommended dosage is 1 tablet every 4 to 6 hours, with a maximum of 4 tablets in a 24-hour period. It's important to note that this medication is not suitable for children under 6 years old, so please avoid using it for that age group. Always follow these guidelines 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 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 should be aware of some potential side effects when using this medication. If you experience nervousness, dizziness, or sleeplessness, it's important to stop using the medication and consult your doctor. Additionally, if your symptoms do not improve within 7 days or if you develop a fever, seek medical advice.

It's crucial not to use this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, or for two weeks after stopping an MAOI. Before using this medication, talk to your doctor if you have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate. In case of an overdose, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

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

Before using this medication, it's important to talk to your doctor if you have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, 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. You should also stop taking the medication and call your doctor if you feel nervous, dizzy, or unable to sleep, or if your symptoms do not improve within seven days or occur with a fever.

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 more severe than typical side effects.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for assistance. Quick action can make a significant difference in ensuring your safety and well-being.

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

If you have a child between the ages of 6 and 11 years, they can take 1 tablet every 4 to 6 hours as needed, but it's important not to exceed 4 tablets in a 24-hour period. For children under 6 years old, this medication is not recommended, so please avoid using it for younger children. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering potential changes in health or how the body processes drugs as we age.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your doctor to ensure safe and effective treatment.

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 may affect you or how your kidney function might influence its use.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 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. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist for clarification.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health is a priority, and your provider can help you navigate any concerns about your treatments.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, ideally around 25°C (77°F). It can safely be kept in a range from 15° to 30°C (59° to 86°F). Always check the outer package before use; if it is opened or if the blister is torn or broken, do not use the product. Additionally, make sure to look at the end flap for the expiration date and lot number to confirm its validity.

By following these simple storage and handling guidelines, you can help maintain the product's effectiveness and safety.

Additional Information

For adults and children aged 12 years and older, you should take 2 tablets every 4 to 6 hours, but do not exceed 8 tablets in a 24-hour period. If you are giving this medication to children aged 6 to 11 years, they should take 1 tablet every 4 to 6 hours, with a maximum of 4 tablets in 24 hours. It is important to note that this medication is not recommended for children under 6 years of age.

FAQ

What is Pseudoephedrine Hydrochloride?

Pseudoephedrine Hydrochloride is a non-drowsy nasal decongestant that temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies.

How should I take Pseudoephedrine Hydrochloride?

Adults and children 12 years and over should take 2 tablets every 4 to 6 hours, not exceeding 8 tablets in 24 hours. Children ages 6 to 11 years should take 1 tablet every 4 to 6 hours, not exceeding 4 tablets in 24 hours.

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 for 2 weeks after stopping an MAOI.

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 fever.

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

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

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

What are the storage instructions for this medication?

Store Pseudoephedrine Hydrochloride at 25°C (77°F), with permitted excursions between 15°-30°C (59°-86°F).

Packaging Info

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

Packaging configurations for Nasal Decongestant.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Pseudoephedrine hydrochloride is a non-drowsy nasal decongestant formulated in a dosage form of 30 mg tablets. Each package contains 24 tablets. The product is designed with tamper-evident packaging; it should not be used if the package is opened or if any blister unit is torn, broken, or shows signs of tampering.

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. It also provides temporary relief from sinus congestion and pressure, effectively alleviating both nasal and sinus congestion.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 tablets every 4 to 6 hours as needed. The total daily dosage must not exceed 8 tablets within a 24-hour period.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours, with a maximum limit of 4 tablets in a 24-hour period.

This medication is not recommended for use in children under 6 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. 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

Use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it is advised to refrain from using this product for a minimum of two weeks following the discontinuation of an MAOI. Healthcare professionals should counsel patients to verify with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Before initiating treatment, it is essential for patients to consult with a healthcare provider if they have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to prostate gland enlargement. These conditions may necessitate additional monitoring or alternative therapeutic strategies.

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 professional if they experience nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within seven days or are accompanied by fever, it is imperative to seek medical advice promptly.

Side Effects

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

Patients should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease, or for a period of 2 weeks following the cessation of an MAOI.

Before using this medication, patients should consult a healthcare provider if they have a history of heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately.

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

Packaging configurations for Nasal Decongestant.
Details

Pediatric Use

Pediatric patients aged 6 to 11 years may take 1 tablet every 4 to 6 hours, with a maximum of 4 tablets in a 24-hour period. The use of this medication is not recommended for children under 6 years of age.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including 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.

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 considered in these populations to ensure the safety of both the mother and the fetus or 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 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 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 the use of this medication. Consequently, there are no 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 available 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, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, there are no details provided concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of several adverse reactions. These include nervousness, dizziness, and sleeplessness. Additionally, there have been reports of symptoms not improving within 7 days or occurring in conjunction with fever. These events were reported voluntarily or identified 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 or contact a Poison Control Center immediately.

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 instruct 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 fever.

It is important to remind patients not to exceed the recommended dosage while using this product. Furthermore, healthcare providers should recommend that patients consult a doctor before use if they have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken. The recommended storage temperature is 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). Healthcare professionals are advised to check the end flap of the package for the expiration date and lot number to ensure product integrity and safety.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 tablets every 4 to 6 hours, with a maximum of 8 tablets in a 24-hour period. For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours, not exceeding 4 tablets in 24 hours. The medication is not recommended for children under 6 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 Nasal Decongestant, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Nasal Decongestant, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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.