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Sudafed Sinus Congestion

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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 2021
Label revision date
November 8, 2024
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 2021
Label revision date
November 8, 2024
Manufacturer
Kenvue Brands LLC
Registration number
M012
NDC root
50580-363
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

SUDAFED CONGESTION is a nasal decongestant that contains pseudoephedrine HCl (30 mg). It is designed to temporarily relieve sinus congestion and pressure, as well as nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. This medication is non-drowsy and comes in a maximum strength formulation, providing you with effective relief from uncomfortable symptoms associated with sinus and nasal congestion.

Uses

If you're dealing with sinus congestion and pressure, this medication can help provide temporary relief. It’s also effective for easing nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. This means that if you're feeling stuffy or blocked up due to these conditions, you can expect some comfort from using this product.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should 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 product is not suitable for children under 6 years of age, so please do not use 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 before using this product.

It's also important to follow the recommended dosage carefully. Exceeding the recommended dose 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. Common reactions may include nervousness, dizziness, and sleeplessness. If you experience any of these symptoms, or if your condition does not improve within 7 days or is accompanied by a fever, it’s important to stop using the medication and consult your doctor.

Additionally, you should avoid this medication if you are currently taking a monoamine oxidase inhibitor (MAOI) or have taken one in the past two weeks. If you have any pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate, consult your doctor before use. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions. Additionally, 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

When it comes to using this medication for children, there are important guidelines to follow. For children aged 6 to 11 years, you can give them 1 tablet every 4 to 6 hours, but make sure they do not take more than 4 tablets in a 24-hour period.

However, if your child is under 6 years old, it is crucial not to use this product at all. Always consult with your healthcare provider if you have any questions or concerns about the appropriate use of this medication for your child.

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 wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

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 if you have hepatic impairment (liver issues).

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

Drug Interactions

It's important to be cautious about drug interactions when considering any new medication. Specifically, you should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, certain psychiatric conditions, or Parkinson's disease. Additionally, you should wait at least two weeks after stopping an MAOI before starting this product. If you're unsure whether your current prescription includes an MAOI, it's best to consult with your doctor or pharmacist.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health and well-being are the top priority, so don't hesitate to ask questions about your treatments.

Storage and Handling

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

By following these simple storage and handling guidelines, you can help maintain the quality and safety of your product.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is SUDAFED CONGESTION?

SUDAFED CONGESTION is a nasal decongestant containing 30 mg of pseudoephedrine HCl, designed to temporarily relieve sinus and nasal congestion.

Who can use SUDAFED CONGESTION?

Adults and children aged 12 years and over can take 2 tablets every 4 to 6 hours, while children aged 6 to 11 years can take 1 tablet every 4 to 6 hours.

What should I do if I have heart disease or high blood pressure?

You should ask a doctor before using SUDAFED CONGESTION if you have heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland.

Are there any contraindications for using SUDAFED CONGESTION?

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

What should I do if I experience side effects?

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

Can I use SUDAFED CONGESTION if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using SUDAFED CONGESTION.

What is the maximum dosage for adults?

Adults should not take more than 8 tablets of SUDAFED CONGESTION in a 24-hour period.

What should I do in case of overdose?

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

How should I store SUDAFED CONGESTION?

Store SUDAFED CONGESTION between 20 - 25°C (68 - 77°F) and do not use it if the blister unit is torn or broken.

Packaging Info

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

Packaging configurations for Sudafed Sinus Congestion.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Pseudoephedrine hydrochloride, a nasal decongestant, is provided in a dosage form of 30 mg per tablet. Each package contains 24 tablets. This formulation is designed to be non-drowsy, allowing for relief from nasal congestion without sedation.

Uses and Indications

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

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

Dosage and Administration

Adults and children 12 years and over are instructed to take 2 tablets every 4 to 6 hours as needed. The maximum allowable dosage is 8 tablets within a 24-hour period.

For children ages 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours. The total daily limit for this age group is 4 tablets within a 24-hour period.

This product 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 dose while using this product is also contraindicated.

Warnings and Precautions

Use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Prior to 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 and require careful monitoring.

Patients must adhere strictly to the recommended dosage. Exceeding the recommended dose can lead to serious health risks and complications.

In the event of experiencing nervousness, dizziness, or sleeplessness, patients should discontinue use and consult a healthcare professional. Furthermore, if symptoms do not improve within seven days or 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 should be aware of the potential adverse reactions associated with the use of this medication. Serious warnings include the contraindication of use in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease.

Common adverse reactions that may necessitate discontinuation of the medication include nervousness, dizziness, or sleeplessness. Patients are advised to stop use and consult a healthcare professional if these symptoms occur or if symptoms do not improve within seven days, particularly if accompanied by a fever.

Additionally, patients should seek medical advice prior to use if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

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

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, if there is any uncertainty regarding the presence of an MAOI in their current prescription medications before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Sudafed Sinus Congestion.
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 product is not recommended for children under 6 years of age.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 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. 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 healthcare providers should be prepared to assess and address any potential complications that may arise.

Management procedures should include a thorough evaluation of the patient's condition, monitoring vital signs, and providing supportive care as necessary. Depending on the specific circumstances of the overdose, additional treatment measures may be required to mitigate the effects of the overdose and ensure patient safety.

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, discontinuation of use and consultation with a physician is recommended. No additional relevant information regarding nonclinical toxicology or animal pharmacology and toxicology is available.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. Additionally, it has been noted that symptoms may not improve within 7 days or may occur in conjunction with a fever.

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 within two weeks of stopping an MAOI. 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 seven days or if they experience symptoms accompanied by a fever.

It is important to remind patients not to exceed the recommended dose 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. Each blister unit must be inspected prior to use; do not use if the blister unit is torn or broken.

For optimal storage, the product should be maintained at a temperature range of 20 to 25°C (68 to 77°F). It is essential to check the side panel for the lot number and expiration date to ensure product integrity and safety.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Sudafed Sinus Congestion, 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 Sudafed Sinus Congestion, 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.

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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.