Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Pseudoephedrine hydrochloride

Last content change checked dailysee data sync status

Active ingredient
Pseudoephedrine Hydrochloride 60 mg
Other brand names
Drug class
alpha-Adrenergic Agonist
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
May 6, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Pseudoephedrine Hydrochloride 60 mg
Other brand names
Drug class
alpha-Adrenergic Agonist
Dosage form
Tablet
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 2019
Label revision date
May 6, 2024
Manufacturer
Major Pharmaceuticals
Registration number
M012
NDC roots
0904-6728, 0904-6907
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

SudoGest™ is a nasal decongestant that contains 60 mg of pseudoephedrine hydrochloride. It is designed to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. Additionally, SudoGest™ helps alleviate sinus congestion and pressure, providing relief without causing drowsiness. This makes it a suitable option for those looking to manage their symptoms while staying alert.

Uses

If you're dealing with nasal congestion from the 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 give you some comfort when you're feeling under the weather.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 tablet every 4 to 6 hours as needed. However, make sure not to exceed 4 tablets in a 24-hour period to avoid potential side effects.

For children under 12 years of age, this medication is not recommended, so please do not use it for younger children. 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 it for at least 2 weeks after stopping an MAOI. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

It's also important to follow the recommended dosage and not exceed it while using this product. Taking more than the advised amount can lead to unwanted effects. 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 product 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: diabetes, heart disease, high blood pressure, thyroid disease, or difficulty urinating due to an enlarged prostate gland. 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 consult 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 diabetes, heart disease, high blood pressure, thyroid disease, 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. In the event of an overdose, seek medical help or contact a Poison Control Center immediately.

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 what you would typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy, and remember that it’s better to be cautious and seek help 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 are considering this medication for your child, it's important to know that it should not be used in children under 12 years of age. For those who are 12 years and older, the recommended dosage is one tablet every 4 to 6 hours, but be sure not to exceed four tablets in a 24-hour period. Always follow these guidelines to ensure your child's safety and well-being.

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

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

Hepatic Impairment

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

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, 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 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 and safety of your product, store it in a dry place at a temperature between 15° and 30°C (59° and 86°F). It's important to keep it within this temperature range to maintain its effectiveness. Additionally, always check the expiration date on the package and use the product before that date to ensure its safety and reliability.

Handling the product with care is essential. Make sure to follow any specific instructions provided with the product to avoid any mishaps. Proper storage and timely use will help you get the most out of your device.

Additional Information

No further information is available.

FAQ

What is SudoGest™?

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

What is the active ingredient in SudoGest™?

The active ingredient in SudoGest™ is Pseudoephedrine Hydrochloride, which is present at a dosage of 60 mg per tablet.

Who can use SudoGest™?

SudoGest™ is intended for adults and children 12 years and older. Children under 12 years of age should not use this product.

What is the recommended dosage for adults and children 12 years and older?

The recommended dosage is 1 tablet every 4 to 6 hours, with a maximum of 4 tablets in 24 hours.

Are there any contraindications for using SudoGest™?

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

Should I consult a doctor before using SudoGest™?

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

What should I do in case of overdose?

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

How should SudoGest™ be stored?

Store SudoGest™ in a dry place at temperatures between 15° – 30°C (59° – 86°F) and use it by the expiration date on the package.

Is SudoGest™ safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using SudoGest™.

Packaging Info

Below are the non-prescription pack sizes of Pseudoephedrine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pseudoephedrine Hydrochloride.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

SudoGest™ is a nasal decongestant formulated to relieve nasal and sinus congestion associated with colds or hay fever. Each tablet contains 60 mg of pseudoephedrine hydrochloride. The product is presented in a dosage form of 30 tablets, designed to provide effective relief without causing drowsiness.

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 12 years and older are advised to take 1 tablet every 4 to 6 hours as needed. The maximum allowable dosage is 4 tablets within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, and for a period of 2 weeks following the discontinuation of an MAOI. This contraindication is due to the potential for serious interactions. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI. Additionally, it is advised not to exceed the recommended dose while using this product.

Warnings and Precautions

Patients should not use this product if they are 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 two weeks following the cessation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have any of the following conditions: diabetes, heart disease, high blood pressure, thyroid disease, or difficulty urinating due to an enlarged prostate gland.

It is crucial for patients to adhere strictly to the recommended dosage when using this product. Exceeding the recommended dose may lead to adverse effects.

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

In the event of an overdose, immediate medical assistance should be obtained, or the patient should contact a Poison Control Center without delay.

Side Effects

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

Common adverse reactions may include those related to pre-existing conditions. Patients should consult a doctor prior to use if they have a history of diabetes, heart disease, high blood pressure, thyroid disease, or difficulty urinating due to an enlarged prostate gland.

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

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson’s disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription medication contains an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Pseudoephedrine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pseudoephedrine Hydrochloride.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours, with a maximum of 4 tablets in a 24-hour period. Caution is advised when administering this medication to ensure adherence to the specified dosing guidelines.

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

Renal Impairment

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

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

Healthcare professionals should be aware that the symptoms of 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 specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. Additionally, there is no information available in the nonclinical toxicology section. Furthermore, no details are present regarding animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one 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.

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

It is important to emphasize to patients the necessity of adhering to the recommended dosage and not exceeding it. Patients with diabetes, heart disease, high blood pressure, thyroid disease, or those who have difficulty urinating due to an enlarged prostate gland should be advised to consult their doctor before using this product to ensure it is safe for their specific health conditions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored in a dry place, maintaining a temperature range of 15° to 30°C (59° to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

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

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

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

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.