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Sinus and Nasal Decongestant

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Active ingredient
Pseudoephedrine Hydrochloride 120 mg
Other brand names
Drug class
alpha-Adrenergic Agonist
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2026
Label revision date
February 17, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Pseudoephedrine Hydrochloride 120 mg
Other brand names
Drug class
alpha-Adrenergic Agonist
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2026
Label revision date
February 17, 2026
Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Registration number
ANDA075153
NDC root
51316-616
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 Hydrochloride Extended-Release Tablets are a non-drowsy medication designed to provide maximum strength relief from sinus pressure and nasal congestion. These tablets work by temporarily relieving nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies, as well as alleviating sinus congestion and pressure.

Each tablet is formulated to offer 12-hour relief, making it a convenient option for managing symptoms throughout the day. If you're experiencing discomfort from sinus or nasal congestion, this medication may help you feel more comfortable and breathe easier.

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. It's designed to make you feel more comfortable when you're dealing with these common respiratory 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 are medications often prescribed for depression, psychiatric 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 before using this product.

It's also important to follow the recommended dosage and not exceed it, as misuse can lead to serious health issues. 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, do not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. 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, 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 are 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 gland. 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.

In the event 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 or contact a Poison Control Center at 1-800-222-1222. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Do not wait for symptoms to worsen; getting prompt assistance can be vital. Always keep emergency contact information handy and be aware of the signs of overdose to ensure 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

It's important to be cautious when considering this product for children. You should not use it for children 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 the safety and well-being of your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

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

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account all the medications and tests you may be using. Always feel free to ask questions and share your complete health history to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it in a dry place at a temperature between 20-25°C (68-77°F). It's important to keep it protected from light to maintain its effectiveness. Before using, check the blister unit; do not use it if it is broken or torn, as this could compromise safety. Additionally, make sure to look at the carton end panel for the lot number and expiration date to confirm that the product is still valid for use.

Additional Information

You should take this medication orally, with adults and children aged 12 years and older advised to take 1 tablet every 12 hours. It's important not to exceed 2 tablets in a 24-hour period. If you have children under 12 years of age, do not use this product for them.

FAQ

What is Pseudoephedrine Hydrochloride Extended-Release Tablets used for?

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

How should adults and children 12 years and over take this medication?

You should take 1 tablet every 12 hours and not exceed 2 tablets in 24 hours.

Can children under 12 years use this product?

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

What should I do if I experience nervousness, dizziness, or sleeplessness?

You should stop using the medication and ask a doctor if these symptoms occur.

Are there any contraindications for using this medication?

Do not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

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 an overdose?

Get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Is it safe to use this medication during pregnancy or breastfeeding?

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

How should I store Pseudoephedrine Hydrochloride Extended-Release Tablets?

Store the tablets at 20-25°C (68-77°F) in a dry place, protected from light, and do not use if the blister unit is broken or torn.

Packaging Info

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

Packaging configurations for Sinus and Nasal Decongestant.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

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 over 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 is also contraindicated.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings The 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, this product 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 there is uncertainty regarding the presence of an MAOI in their prescription medications.

General Precautions 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

  • Difficulty urinating due to an enlarged prostate gland

Emergency Medical Help Instructions In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Stop Taking and Call Your Doctor Instructions Patients should discontinue use and consult a healthcare professional if they experience any of the following:

  • Nervousness, dizziness, or sleeplessness

  • Symptoms that do not improve within seven days or occur alongside a fever

These precautions are essential for the safe administration of the product and to mitigate potential risks associated with its use.

Side Effects

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

Before initiating treatment, patients with pre-existing conditions should consult a healthcare provider. This includes individuals with heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland.

The product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued an MAOI within the past two weeks. Patients uncertain about whether their prescription includes an MAOI should seek clarification from a healthcare professional or pharmacist prior to use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Sinus and Nasal Decongestant.
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.

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 efficacy, 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 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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 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. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely 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.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 drug 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. 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 a blister pack configuration. It should be stored at a temperature range of 20-25°C (68-77°F) in a dry place, ensuring protection from light. Healthcare professionals are advised to inspect the blister unit prior to use; the product should not be utilized if the blister unit is broken or torn. For additional information, including the lot number and expiration date, please refer to the carton end panel.

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 Sinus and 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 Sinus and 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

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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.