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Sudogest 12 Hour

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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 2019
Label revision date
October 30, 2025
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 2019
Label revision date
October 30, 2025
Manufacturer
Major Pharmaceuticals
Registration number
ANDA075153
NDC root
0904-6754
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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™ 12 hour is a medication that contains pseudoephedrine hydrochloride, which is an active ingredient known for its effectiveness as a nasal decongestant. It is designed to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies, as well as alleviate sinus congestion and pressure.

This product is formulated as extended-release tablets, providing maximum strength relief without causing drowsiness, making it suitable for use throughout the day. Each package contains 10 coated caplets, each delivering 120 mg of the active ingredient.

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 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

It's important to use this medication responsibly. You should never exceed the recommended dosage, as doing so can lead to serious health risks. While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, it's always best to follow the guidelines provided by your healthcare professional to ensure your safety and well-being. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor or pharmacist for guidance.

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, avoid this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one in the past two weeks, as this can lead to serious interactions. 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, 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 an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop using this product and call your doctor if you experience nervousness, dizziness, or sleeplessness, 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. 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 take overdosing seriously. If you notice any of these symptoms or have concerns about a possible overdose, don’t hesitate to reach out for help right away. Your safety is 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

It’s important to be cautious when considering this product for children. You should not use it for kids under 12 years old. For those aged 12 and older, the recommended dosage is one tablet every 12 hours, but make sure not to exceed two tablets in a 24-hour period. Always follow these guidelines to ensure the safety and well-being of 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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. 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 or monitoring for renal impairment (kidney issues). This means that there are no tailored guidelines for how the medication should be adjusted based on your kidney function.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that your treatment is safe and effective for you.

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 discuss any concerns regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your full list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness 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 quality. Before use, check the blister unit; do not use it if it is broken or torn, as this could compromise the product. Additionally, make sure to refer to 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. For adults and children 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. If you have a child under 12 years old, do not use this product for them. Always follow the dosage instructions to ensure safe and effective use.

FAQ

What is SudoGest™ 12 hour?

SudoGest™ 12 hour is a nasal decongestant that contains pseudoephedrine hydrochloride extended release tablets, 120 mg.

What does SudoGest™ 12 hour relieve?

It temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies, as well as sinus congestion and pressure.

Who can take SudoGest™ 12 hour?

Adults and children 12 years and over can take it, but it should not be used in children under 12 years of age.

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

The recommended dosage is 1 tablet every 12 hours, with a maximum of 2 tablets in 24 hours.

Are there any contraindications for using SudoGest™ 12 hour?

No specific contraindications are mentioned, but do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if I experience side effects?

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

What precautions should I take before using SudoGest™ 12 hour?

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 overdose?

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

Is SudoGest™ 12 hour safe to use during pregnancy or breastfeeding?

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

How should I store SudoGest™ 12 hour?

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

Packaging Info

Below are the non-prescription pack sizes of Sudogest 12 Hour (pseudoephedrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sudogest 12 Hour.
Details

Drug Information (PDF)

This file contains official product information for Sudogest 12 Hour, 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.

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 not recommended for use in children under 12 years of age.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dosage may lead to adverse effects.

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 discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Healthcare professionals should exercise caution and advise patients to seek medical consultation 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.

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

Patients should 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 promptly.

Side Effects

Patients may experience a range of adverse reactions while using 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 arise in patients with pre-existing conditions. It is recommended that individuals with heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland consult a healthcare provider before using this product.

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 should seek clarification from a doctor or pharmacist prior to use.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Sudogest 12 Hour (pseudoephedrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sudogest 12 Hour.
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

There is no specific information available 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments or monitoring provided in the prescribing information. Therefore, healthcare professionals should exercise caution when considering treatment for patients with reduced kidney function, as the absence of guidance 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 the use of 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. 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 it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications 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, it is recommended to discontinue use and seek medical advice. Additionally, if symptoms do not improve within seven days or are accompanied by a fever, medical consultation should be sought.

No information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Furthermore, there is no data provided on animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, and sleeplessness. Cardiovascular effects such as increased blood pressure, palpitations, and tachycardia have also been noted. Gastrointestinal disturbances, including nausea and vomiting, were reported. Additionally, allergic reactions have been documented, which encompass rash, pruritus, and angioedema.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important for patients to be informed that they should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be instructed 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.

Patients must be reminded not to exceed the recommended dosage while using this product. Furthermore, healthcare providers should encourage patients to consult with a doctor prior to 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. This information is crucial for ensuring safe and effective use of the product.

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 used if the blister unit is broken or torn. For tracking purposes, the lot number and expiration date can be found on the end panel of the carton.

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 within a 24-hour period. The product is not recommended for use in children under 12 years of age. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Sudogest 12 Hour, 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 Sudogest 12 Hour, 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.