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Nasal Decongestant
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- Active ingredient
- Pseudoephedrine Hydrochloride 30 mg
- Other brand names
- 12 Hour Nasal Decongestant (by Cardinal Health)
- 12 Hour Nasal Decongestant (by Cvs Pharmacy)
- Careone Nasal and Sinus Decongestant (by American Sales Company)
- Careone Nasal and Sinus Decongestant (by American Sales Company)
- Childrens Sudafed (by Kenvue Brands Llc)
- Equaline 12 Hour Decongestant (by United Natural Foods, Inc. Dba Unfi)
- Equaline Nasal Decongestant (by United Natural Foods, Inc. Dba Unfi)
- Equate Sinus 12 Hour (by Wal-Mart Stores Inc)
- Good Neighbor Pharmacy Nasal Decongestant (by Amerisource Bergen)
- Good Sense Nasal Decongestant (by L. Perrigo Company)
- Good Sense Suphedrine (by L. Perrigo Company)
- Leader 12 Hour Nasal Decongestant (by Cardinal Health 110, Llc. Dba Leader)
- Leader 12 Hour Sinus Nasal Decongestant (by Cardinal Health 110, Llc. Dba Leader)
- Leader Nasal Decongestant (by Cardinal Health 110, Llc. Dba Leader)
- Nasal Decongestant (by Amerisource Bergen)
- Nasal Decongestant (by Better Living Brands, Llc)
- Nasal Decongestant (by Chain Drug Marketing Association Inc)
- Nasal Decongestant (by Cvs Pharmacy)
- Nasal Decongestant (by Cvs Pharmacy)
- Nasal Decongestant (by H E B)
- Nasal Decongestant (by L. N. K. International, Inc.)
- Nasal Decongestant (by Meijer Distribution Inc)
- Nasal Decongestant (by Meijer Distribution Inc)
- Nasal Decongestant (by Publix Super Markets Inc)
- Nasal Decongestant (by Rugby Laboratories)
- Nasal Decongestant (by Strategic Sourcing Services Llc)
- Nasal Decongestant (by Strategic Sourcing Services Llc)
- Nasal Decongestant (by Strategic Sourcing Services)
- Nasal Decongestant (by Walgreen Company)
- Nasal Decongestant D (by Walgreen Company)
- Pseudoephedrine Hcl (by Aurohealth Llc)
- Pseudoephedrine Hcl (by Better Living Brands Llc)
- Pseudoephedrine Hcl (by Major Pharmaceuticals)
- Pseudoephedrine Hydrochloride (by Aurohealth Llc)
- Pseudoephedrine Hydrochloride (by Cardinal Health 110, Llc Dba Leader)
- Pseudoephedrine Hydrochloride (by Cardinal Health)
- Pseudoephedrine Hydrochloride (by Chain Drug Consortium, Llc)
- Pseudoephedrine Hydrochloride (by Chain Drug Marketing Association Inc.)
- Pseudoephedrine Hydrochloride (by Cvs Pharmacy)
- Pseudoephedrine Hydrochloride (by Discount Drug Mart)
- Pseudoephedrine Hydrochloride (by Heb)
- Pseudoephedrine Hydrochloride (by Major Pharmaceuticals)
- Pseudoephedrine Hydrochloride (by Major Pharmaceuticals)
- Pseudoephedrine Hydrochloride (by Major Pharmaceuticals)
- Pseudoephedrine Hydrochloride (by Meijer Distribution, Inc.)
- Pseudoephedrine Hydrochloride (by Ohm Laboratories Inc.)
- Pseudoephedrine Hydrochloride (by Ohm Laboratories Inc.)
- Pseudoephedrine Hydrochloride (by Padagis Israel Pharmaceuticals Ltd)
- Pseudoephedrine Hydrochloride (by Padagis Israel Pharmaceuticals Ltd)
- Pseudoephedrine Hydrochloride (by Publix Super Markets Inc)
- Pseudoephedrine Hydrochloride (by Safeway Inc.)
- Pseudoephedrine Hydrochloride (by Sam's West Inc)
- Pseudoephedrine Hydrochloride (by Shopko Stores Operating Co. , Llc)
- Pseudoephedrine Hydrochloride (by Sportpharm Llc)
- Pseudoephedrine Hydrochloride (by Sportpharm Llc)
- Pseudoephedrine Hydrochloride (by Strategic Sourcing Services Llc)
- Pseudoephedrine Hydrochloride (by Strategic Sourcing Services Llc)
- Pseudoephedrine Hydrochloride (by The Kroger Company)
- Pseudoephedrine Hydrochloride (by Walgreen Co.)
- Pseudoephedrine Hydrochloride (by Walgreen Company)
- Sinus (by Kroger Company)
- Sinus 12 Hour (by L. Perrigo Company)
- Sinus and Congestion (by Wal-Mart Stores Inc)
- Sinus and Nasal Decongestant (by Cvs Woonsocket Prescription Center, Incorporated)
- Sinus and Nasal Decongestant (by Cvs Woonsocket Prescription Center, Incorporated)
- Sinus and Nasal Decongestant (by Cvs Woonsocket Prescription Center, Incorporated)
- Sinus Congestion (by Chain Drug Marketing Association, Inc.)
- Sinus Decongestion (by Kroger Company)
- Sinus Pressure and Congestion Relief (by Rite Aid Corporation)
- Sinus Pressure and Congestion Relief (by Rite Aid Corporation)
- Sudafed Sinus Congestion (by Kenvue Brands Llc)
- Sudafed Sinus Congestion 12 Hour (by Kenvue Brands Llc)
- Sudogest (by Major Pharmaceuticals)
- Sudogest 12 Hour (by Major Pharmaceuticals)
- Sudogest Nasal Decongestant (by Major Pharmaceuticals)
- Topcare 12 Hour Decongestant (by Topco Associates Llc)
- Topcare Nasal Decongestant (by Topco Associates Llc)
- Zephrex D (by L. Perrigo Company)
- View full label-group details →
- Drug class
- alpha-Adrenergic Agonist
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 1981
- Label revision date
- July 18, 2025
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Pseudoephedrine Hydrochloride 30 mg
- Other brand names
- 12 Hour Nasal Decongestant (by Cardinal Health)
- 12 Hour Nasal Decongestant (by Cvs Pharmacy)
- Careone Nasal and Sinus Decongestant (by American Sales Company)
- Careone Nasal and Sinus Decongestant (by American Sales Company)
- Childrens Sudafed (by Kenvue Brands Llc)
- Equaline 12 Hour Decongestant (by United Natural Foods, Inc. Dba Unfi)
- Equaline Nasal Decongestant (by United Natural Foods, Inc. Dba Unfi)
- Equate Sinus 12 Hour (by Wal-Mart Stores Inc)
- Good Neighbor Pharmacy Nasal Decongestant (by Amerisource Bergen)
- Good Sense Nasal Decongestant (by L. Perrigo Company)
- Good Sense Suphedrine (by L. Perrigo Company)
- Leader 12 Hour Nasal Decongestant (by Cardinal Health 110, Llc. Dba Leader)
- Leader 12 Hour Sinus Nasal Decongestant (by Cardinal Health 110, Llc. Dba Leader)
- Leader Nasal Decongestant (by Cardinal Health 110, Llc. Dba Leader)
- Nasal Decongestant (by Amerisource Bergen)
- Nasal Decongestant (by Better Living Brands, Llc)
- Nasal Decongestant (by Chain Drug Marketing Association Inc)
- Nasal Decongestant (by Cvs Pharmacy)
- Nasal Decongestant (by Cvs Pharmacy)
- Nasal Decongestant (by H E B)
- Nasal Decongestant (by L. N. K. International, Inc.)
- Nasal Decongestant (by Meijer Distribution Inc)
- Nasal Decongestant (by Meijer Distribution Inc)
- Nasal Decongestant (by Publix Super Markets Inc)
- Nasal Decongestant (by Rugby Laboratories)
- Nasal Decongestant (by Strategic Sourcing Services Llc)
- Nasal Decongestant (by Strategic Sourcing Services Llc)
- Nasal Decongestant (by Strategic Sourcing Services)
- Nasal Decongestant (by Walgreen Company)
- Nasal Decongestant D (by Walgreen Company)
- Pseudoephedrine Hcl (by Aurohealth Llc)
- Pseudoephedrine Hcl (by Better Living Brands Llc)
- Pseudoephedrine Hcl (by Major Pharmaceuticals)
- Pseudoephedrine Hydrochloride (by Aurohealth Llc)
- Pseudoephedrine Hydrochloride (by Cardinal Health 110, Llc Dba Leader)
- Pseudoephedrine Hydrochloride (by Cardinal Health)
- Pseudoephedrine Hydrochloride (by Chain Drug Consortium, Llc)
- Pseudoephedrine Hydrochloride (by Chain Drug Marketing Association Inc.)
- Pseudoephedrine Hydrochloride (by Cvs Pharmacy)
- Pseudoephedrine Hydrochloride (by Discount Drug Mart)
- Pseudoephedrine Hydrochloride (by Heb)
- Pseudoephedrine Hydrochloride (by Major Pharmaceuticals)
- Pseudoephedrine Hydrochloride (by Major Pharmaceuticals)
- Pseudoephedrine Hydrochloride (by Major Pharmaceuticals)
- Pseudoephedrine Hydrochloride (by Meijer Distribution, Inc.)
- Pseudoephedrine Hydrochloride (by Ohm Laboratories Inc.)
- Pseudoephedrine Hydrochloride (by Ohm Laboratories Inc.)
- Pseudoephedrine Hydrochloride (by Padagis Israel Pharmaceuticals Ltd)
- Pseudoephedrine Hydrochloride (by Padagis Israel Pharmaceuticals Ltd)
- Pseudoephedrine Hydrochloride (by Publix Super Markets Inc)
- Pseudoephedrine Hydrochloride (by Safeway Inc.)
- Pseudoephedrine Hydrochloride (by Sam's West Inc)
- Pseudoephedrine Hydrochloride (by Shopko Stores Operating Co. , Llc)
- Pseudoephedrine Hydrochloride (by Sportpharm Llc)
- Pseudoephedrine Hydrochloride (by Sportpharm Llc)
- Pseudoephedrine Hydrochloride (by Strategic Sourcing Services Llc)
- Pseudoephedrine Hydrochloride (by Strategic Sourcing Services Llc)
- Pseudoephedrine Hydrochloride (by The Kroger Company)
- Pseudoephedrine Hydrochloride (by Walgreen Co.)
- Pseudoephedrine Hydrochloride (by Walgreen Company)
- Sinus (by Kroger Company)
- Sinus 12 Hour (by L. Perrigo Company)
- Sinus and Congestion (by Wal-Mart Stores Inc)
- Sinus and Nasal Decongestant (by Cvs Woonsocket Prescription Center, Incorporated)
- Sinus and Nasal Decongestant (by Cvs Woonsocket Prescription Center, Incorporated)
- Sinus and Nasal Decongestant (by Cvs Woonsocket Prescription Center, Incorporated)
- Sinus Congestion (by Chain Drug Marketing Association, Inc.)
- Sinus Decongestion (by Kroger Company)
- Sinus Pressure and Congestion Relief (by Rite Aid Corporation)
- Sinus Pressure and Congestion Relief (by Rite Aid Corporation)
- Sudafed Sinus Congestion (by Kenvue Brands Llc)
- Sudafed Sinus Congestion 12 Hour (by Kenvue Brands Llc)
- Sudogest (by Major Pharmaceuticals)
- Sudogest 12 Hour (by Major Pharmaceuticals)
- Sudogest Nasal Decongestant (by Major Pharmaceuticals)
- Topcare 12 Hour Decongestant (by Topco Associates Llc)
- Topcare Nasal Decongestant (by Topco Associates Llc)
- Zephrex D (by L. Perrigo Company)
- View full label-group details →
- Drug class
- alpha-Adrenergic Agonist
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Prescription status
- OTC (over the counter)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 1981
- Label revision date
- July 18, 2025
- Manufacturer
- Chain Drug Consortium
- Registration number
- M012
- NDC root
- 68016-473
- Drug Information (PDF)
- Prescribing information, PDF file
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
Premier Value is a maximum strength nasal decongestant that contains 30 mg of pseudoephedrine HCl (a medication that helps relieve nasal congestion). It is designed to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies, as well as to alleviate sinus congestion and pressure. This non-drowsy formula is available in a pack of 96 tablets, making it a convenient option for those seeking relief from congestion.
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 experiencing sinus congestion and pressure, this medication can also help alleviate those symptoms. It's designed to provide you with some comfort when dealing with these common issues.
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 are medications often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, do not use this product for at least two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist.
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 using 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 contains 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 unable to sleep, 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.
Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for assistance. Quick action can make a significant difference in ensuring your safety and well-being.
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 consult with your child's healthcare provider if you have any questions or concerns about their medication.
Geriatric Use
While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best course of action based on individual health needs and any other medications being taken.
Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.
Renal Impairment
If you have kidney problems, it's important to know that the 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 may affect you 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 monitor your kidney function and make any necessary adjustments to your treatment plan.
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, 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. 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 is a priority, and your provider can help you navigate any concerns.
Storage and Handling
To ensure the best quality and safety of your product, store it at room temperature, ideally around 25ºC (77ºF). It’s acceptable for the temperature to vary between 15ºC and 30ºC (59ºF to 86ºF) occasionally. Always check the outer package before use; if it’s 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 that the product is still valid and safe to use.
Additional Information
For adults and children aged 12 years and older, you should take 2 tablets every 4 to 6 hours, but do not exceed 8 tablets in a 24-hour period. If your child is between 6 and 11 years old, they can take 1 tablet every 4 to 6 hours, with a maximum of 4 tablets in 24 hours. It is important to avoid using this medication for children under 6 years old.
Currently, there is no additional information available regarding laboratory tests, abuse potential, or patient counseling.
FAQ
What is Premier Value?
Premier Value is a maximum strength nasal decongestant that contains Pseudoephedrine HCl 30 mg and is non-drowsy.
What does Premier Value 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.
What is the recommended dosage for adults and children 12 years and over?
You should take 2 tablets every 4 to 6 hours, not exceeding 8 tablets in 24 hours.
What is the recommended dosage for children ages 6 to 11 years?
Children ages 6 to 11 years should take 1 tablet every 4 to 6 hours, not exceeding 4 tablets in 24 hours.
Can children under 6 years use Premier Value?
No, do not use Premier Value for children under 6 years.
Are there any contraindications for using Premier Value?
Do not use 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 use and ask a doctor if you experience nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days or occur with fever.
What precautions should I take before using Premier Value?
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 it safe to use Premier Value during pregnancy or breastfeeding?
If you are pregnant or breastfeeding, ask a health professional before use.
Packaging Info
Below are the non-prescription pack sizes of Nasal Decongestant (pseudoephedrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated | 30 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 30 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
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.
Description
Pseudoephedrine hydrochloride, a nasal decongestant, is provided in a dosage form of 30 mg per tablet. This formulation is designed to relieve nasal congestion without causing drowsiness. The product is packaged in a total of 96 tablets. It is important to note that the packaging is tamper-evident; the product should not be used if the package is opened or if any blister unit is torn, broken, or shows signs of tampering.
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 as needed, 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 a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.
Exceeding the recommended dosage while using this product is also contraindicated.
Warnings and Precautions
It is imperative to adhere to the following warnings and precautions when considering the use of this product.
Warnings 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, this product 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 Prior to using this product, patients should seek medical advice if they have any of the following conditions: diabetes, heart disease, high blood pressure, thyroid disease, or difficulty in urination due to prostate gland enlargement. These conditions may necessitate closer monitoring and evaluation by a healthcare provider.
Emergency Medical Help Instructions In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center without delay.
Stop Taking and Call Your Doctor Instructions Patients are advised 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 may experience a range of adverse reactions while using this product. Serious adverse reactions warrant immediate medical attention and include 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 fever, medical advice should be sought.
It is important to note that this product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients must refrain from using this product for at least 2 weeks after discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in a current prescription, patients should 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, 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 Nasal Decongestant (pseudoephedrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated | 30 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 30 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
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 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 adverse effects or changes in therapeutic response, 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 currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed 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 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 aware that the specific symptoms of an 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 the specific substance is known, targeted interventions may be employed to counteract the effects of the overdose.
It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.
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 fever, medical consultation should be sought.
No information is available regarding nonclinical toxicology or animal pharmacology and toxicology.
Postmarketing Experience
No postmarketing experience details are available in the insert text.
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 crucial to inform patients that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should be instructed to refrain from using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist.
Patients should be informed 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.
It is important to emphasize to patients the necessity of adhering to the recommended dosage and not exceeding it. Healthcare providers should also encourage patients to consult with a doctor prior to use if they have any of the following conditions: diabetes, heart disease, high blood pressure, thyroid disease, or difficulty in urination due to an enlarged prostate gland.
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
Patients aged 12 years and older are advised to take 2 tablets every 4 to 6 hours, with a maximum of 8 tablets in a 24-hour period. For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours, not exceeding 4 tablets in 24 hours. The medication is not recommended for children under 6 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 Nasal Decongestant, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.