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12 Hour Nasal Decongestant

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Active ingredient
Pseudoephedrine Hydrochloride 120 mg
Other brand names
Drug class
alpha-Adrenergic Agonist
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1999
Label revision date
May 23, 2019
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 1999
Label revision date
May 23, 2019
Manufacturer
CVS Pharmacy
Registration number
ANDA075153
NDC root
59779-703
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

Pseudoephedrine hydrochloride extended-release tablets are a non-drowsy medication designed to provide 12 hours of relief from nasal congestion. This medication is commonly used to alleviate symptoms caused by the common cold, hay fever, or other upper respiratory allergies. It also helps relieve sinus congestion and pressure, making it a useful option for those experiencing discomfort from these conditions.

These tablets contain maximum strength pseudoephedrine, which works by temporarily reducing swelling in the nasal passages, allowing you to breathe more easily. Each package includes 10 coated caplets, which are capsule-shaped for easier swallowing.

Uses

You can use this medication to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. If you're feeling pressure or congestion in your sinuses, this medication can also help alleviate those symptoms. It's designed to provide you with some comfort when you're dealing with these common issues.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 tablet every 12 hours. It's important not to exceed 2 tablets in a 24-hour period to ensure your safety and avoid potential side effects.

For children under 12 years of age, this product is not recommended, so please do not use it for younger children. Always follow these guidelines to ensure effective and safe use of the medication.

What to Avoid

It's important to follow the recommended dosage when using this medication. Exceeding the recommended amount can lead to unwanted effects. Always use the medication as directed to ensure your safety and well-being. If you have any questions or concerns about your dosage, please consult your healthcare provider for guidance.

Side Effects

If you experience nervousness, dizziness, or trouble sleeping 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 stopped taking one within the last two weeks. If you're unsure whether your medication includes an MAOI, please ask your doctor or pharmacist.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson’s disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you are unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

Before using this product, it’s important to talk to your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. If you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within seven days or occur with a fever, stop using the product and contact your doctor.

In 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 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 your child. If your child is under 12 years old, you should not use this product for them. Always consult with a healthcare professional if you have questions about the appropriate treatments for your child's age and health needs. Your child's safety is the top priority, so make sure to follow these guidelines carefully.

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 such as heart disease, high blood pressure, thyroid issues, diabetes, or difficulty urinating due to an enlarged prostate. These conditions can affect how the medication works in your body.

For adults and children aged 12 and older, the recommended dosage is one tablet every 12 hours, with a maximum of two tablets in a 24-hour period. Please note that this product is not suitable for children under 12 years of age. Always follow your healthcare provider's advice to ensure safe and effective use.

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 any concerns related to 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 of your product, store it in a dry place at a temperature between 20-25°C (68-77°F). It's important to keep the product protected from light to maintain its effectiveness. Before using, always check the blister unit; do not use it if the packaging is broken or torn, as this could compromise safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, with one tablet every 12 hours. It's important not to exceed two tablets in a 24-hour period. If you are pregnant or breastfeeding, consult a healthcare professional before using this medication. Always keep it out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Pseudoephedrine Hydrochloride Extended-Release Tablets used for?

It is a 12-hour nasal decongestant that temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies, as well as sinus congestion and pressure.

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

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

Is this medication safe for children under 12 years?

No, you should not use this product in children under 12 years of age.

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

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

Are there any contraindications for using this medication?

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

What precautions should I take before using this medication?

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

What should I do in case of an overdose?

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

Can I use this medication if I am pregnant or breastfeeding?

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

How should I store this medication?

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

Packaging Info

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

Packaging configurations for 12 Hour Nasal Decongestant.
Details

Drug Information (PDF)

This file contains official product information for 12 Hour Nasal Decongestant, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Pseudoephedrine hydrochloride extended-release tablets are formulated as a nasal decongestant, each containing 120 mg of the active ingredient. These tablets are designed for maximum strength relief and are presented in a capsule-shaped form. The product is supplied in a package containing 10 coated caplets.

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 older are instructed to take 1 tablet every 12 hours. The maximum allowable dosage is 2 tablets within a 24-hour period.

This product is contraindicated for use in children under 12 years of age.

Contraindications

There are no specific contraindications listed 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, the product should not be used for at least two weeks following the discontinuation 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 use.

Healthcare professionals should advise patients to seek medical guidance before using this product 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 warrant careful consideration before initiating treatment.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

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 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 consult a healthcare provider 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.

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 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, certain psychiatric conditions, or 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 includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for 12 Hour Nasal Decongestant.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this product. Safety and efficacy have not been established in this age group, and therefore, its use is contraindicated. Healthcare professionals are advised to consider alternative treatments for pediatric patients within this age range.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this product, particularly if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties related to an enlarged prostate gland.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 12 hours, with a maximum of 2 tablets within a 24-hour period. It is important to note that this product is not recommended for use in children under 12 years of age.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, ensuring appropriate monitoring and consideration of any underlying health conditions that may affect safety and efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

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

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific condition.

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 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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may develop as a result of the overdose.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any nonclinical toxicology data. Additionally, no details are provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

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 occur alongside a fever.

Providers should emphasize the importance of adhering to the recommended dosage and not exceeding it while using this product. Furthermore, patients should be encouraged to consult with their healthcare provider 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 precautionary approach will help ensure the 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. It is essential to protect the product from light exposure. Additionally, the product must not be used if the blister unit is broken or torn.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of one tablet every 12 hours, not to exceed two tablets within a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential 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 at 1-800-222-1222.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for 12 Hour 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 12 Hour 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

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.