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Nasal Decongestant

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This product has been discontinued

Active ingredient
Pseudoephedrine Hydrochloride 30 mg
Other brand names
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
April 10, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Pseudoephedrine Hydrochloride 30 mg
Other brand names
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
April 10, 2025
Manufacturer
Strategic Sourcing Services LLC
Registration number
M012
NDC root
70677-0005
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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If you are a consumer or patient please visit this version.

Drug Overview

Sunmark® is a nasal decongestant that contains pseudoephedrine HCl (30 mg) as its active ingredient. It is designed to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. Additionally, it helps alleviate sinus congestion and pressure, providing you with comfort when you're feeling stuffy.

This product is formulated to be non-drowsy, making it a suitable option for those who need relief without the side effects of drowsiness. Sunmark® is comparable to Sudafed® Sinus Congestion, offering effective relief for your nasal and sinus discomfort.

Uses

If you're dealing with nasal congestion from a common cold, hay fever, or other upper respiratory allergies, this medication can help provide temporary relief. It works by easing the swelling in your nasal passages, making it easier for you to breathe.

Additionally, if you're experiencing sinus congestion and pressure, this medication can also help alleviate those symptoms, giving you a sense of comfort and relief. Remember, these effects are temporary, so it's important to follow the recommended guidelines for use.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you 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 is a type of medication used 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 taking it and consult your doctor. Additionally, if your symptoms do not improve within 7 days or if you develop a fever, seek medical advice.

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, psychiatric conditions, or Parkinson's disease. It's also advised to wait at least 2 weeks after stopping an MAOI before using this product. If you're unsure whether your prescription includes an MAOI, please check with 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'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: diabetes, heart disease, high blood pressure, thyroid disease, 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 using the product and call your doctor if you feel nervous, dizzy, or have trouble sleeping, 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.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always prioritize your health and reach out for assistance if you have any concerns about an overdose.

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

If you are an older adult or caring for one, it's important to consult with a doctor before using this medication, especially if there are existing health concerns. Specifically, you should seek medical advice if you have heart disease, high blood pressure, or experience difficulty urinating due to an enlarged prostate gland. These conditions can affect how the medication works and may require special consideration to ensure safety and effectiveness. Always prioritize open communication with your healthcare provider to address any potential risks.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication, especially if you experience difficulty urinating due to an enlarged prostate gland. Your healthcare provider can help determine if this medication is safe for you and may suggest adjustments to your dosage or monitoring based on your kidney function. Always prioritize open communication with your doctor regarding your kidney health and any medications you are considering.

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 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.

Always consult with your healthcare provider or pharmacist if you're unsure whether your current medications include an MAOI. They can help ensure that you avoid potentially harmful interactions and keep your treatment safe and effective.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally around 25ºC (77ºF). It can safely be kept in a range from 15ºC to 30ºC (59ºF to 86ºF). 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 safety and effectiveness.

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

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Always keep this medication out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center.

FAQ

What is sunmark®?

Sunmark® is a nasal decongestant that temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies.

What is the active ingredient in sunmark®?

The active ingredient in sunmark® is pseudoephedrine HCl 30 mg.

How should adults and children 12 years and over take sunmark®?

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

Can children under 6 years use sunmark®?

No, sunmark® should not be used in children under 6 years.

What should I do if I experience nervousness or dizziness while using sunmark®?

If you experience nervousness, dizziness, or sleeplessness, stop using sunmark® and ask a doctor.

Are there any contraindications for using sunmark®?

Yes, do not use sunmark® 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 sunmark®?

Ask a doctor before use if you have diabetes, heart disease, high blood pressure, thyroid disease, or difficulty urinating due to prostate enlargement.

What should I do in case of overdose?

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

Is sunmark® safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using sunmark®.

How should sunmark® be stored?

Store sunmark® at 25ºC (77ºF), with excursions permitted between 15º-30ºC (59º-86ºF).

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

sunmark® is a nasal decongestant formulation containing 30 mg of pseudoephedrine hydrochloride as the active ingredient. This product is designed for the relief of sinus pressure and congestion, providing maximum strength efficacy. It is formulated to be non-drowsy, allowing for use without sedation. The product is available in a package size of 24 tablets.

The product features a tamper-evident warning, indicating that it should not be used if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. It is important to note that this product is not manufactured or distributed by Johnson & Johnson Corporation, the owner of the registered trademark Sudafed Sinus Congestion.

sunmark® is distributed by McKesson Corp., through Strategic Sourcing Services LLC, located in Memphis, TN 38141. The copyright for this product is held by McKesson Corporation, with a revision date of August 2021. For further information, visit www.sunmarkbrand.com.

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 2 tablets every 4 to 6 hours as needed. The maximum allowable dosage is 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 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 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 a prescription monoamine oxidase inhibitor (MAOI), which includes certain 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 there is uncertainty regarding the presence of an MAOI in their prescription medications.

General precautions should be taken prior to use. Patients should be advised to seek medical consultation if they have any of the following conditions: diabetes, heart disease, high blood pressure, thyroid disease, or difficulty urinating due to prostate gland enlargement. These conditions may necessitate closer monitoring and evaluation by a healthcare provider.

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately to ensure appropriate management.

Patients should be instructed to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, medical advice should be sought promptly.

Side Effects

Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, medical advice should be sought.

It is contraindicated to use this product in conjunction with a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Furthermore, patients should refrain from using this product for a period of 2 weeks following the cessation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, patients are advised to consult a doctor or pharmacist prior to use.

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 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 should consult a healthcare provider prior to using this medication, particularly if they have a history of heart disease, high blood pressure, or experience difficulty in urination due to prostate gland enlargement. These conditions may necessitate careful monitoring and potential dosage adjustments to ensure safety and efficacy in this population. It is essential for healthcare providers to evaluate the individual health status of geriatric patients to mitigate risks associated with these underlying health issues.

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 should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

Nonclinical Toxicology

No teratogenic effects have been observed in the studies conducted. Additionally, there are no reported non-teratogenic effects. The available data does not provide any details regarding nonclinical toxicology. Furthermore, there are no findings related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be encouraged to consult with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and seek medical advice if their symptoms do not improve within seven days or if they experience symptoms accompanied by fever.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and not exceeding it while using this product. Patients with diabetes, heart disease, high blood pressure, thyroid disease, or those experiencing difficulty in urination due to an enlarged prostate gland should be advised to consult their doctor before using this product.

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.

Storage conditions require the product to be maintained at a temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). For proper identification, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately. No additional information is available regarding laboratory tests, abuse potential, 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

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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.