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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 Consortium)
- 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)
- 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
- October 10, 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 Consortium)
- 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)
- 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
- October 10, 2025
- Manufacturer
- CHAIN DRUG MARKETING ASSOCIATION INC
- Registration number
- M012
- NDC root
- 63868-802
- 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
QC® (Quality Choice) is a maximum strength, non-drowsy nasal decongestant that contains pseudoephedrine HCl (30 mg per tablet). 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 product is comparable to the active ingredient found in SUDAFED® SINUS CONGESTION, although it is not manufactured or distributed by Johnson & Johnson Corporation. QC® is distributed by C.D.M.A., Inc., and comes in a package of 48 tablets.
Uses
If you're dealing with nasal congestion from a common cold, hay fever, or other upper respiratory allergies, this medication can help provide temporary relief. It works by easing the swelling in your nasal passages, making it easier for you to breathe.
Additionally, if you're experiencing sinus congestion and pressure, this medication can also help alleviate those symptoms, giving you a sense of comfort and relief. Remember, these effects are temporary, so it's important to follow the recommended guidelines for use.
Dosage and Administration
If you are an adult or a child aged 12 years and older, you can take 2 tablets every 4 to 6 hours as needed. However, make sure not to exceed 8 tablets in a 24-hour period to stay safe.
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 effective and safe 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 certain medications 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 are unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist.
While using this product, it’s important not to exceed the recommended dosage. Taking more than the advised amount can lead to serious health risks, including potential misuse or dependence (a condition where your body becomes reliant on a substance). Always prioritize your safety and well-being by following 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 medication used for depression, psychiatric conditions, or Parkinson’s disease. It's also advised to wait at least 2 weeks after stopping an MAOI before using this product. If you're unsure whether your prescription includes an MAOI, please check with your doctor or pharmacist.
Warnings and Precautions
You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, certain psychiatric conditions, or Parkinson’s disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you 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, diabetes, thyroid disease, high blood pressure, 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 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 health and safety are 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
If your child is 12 years or older, they can take 2 tablets every 4 to 6 hours, but make sure they do not exceed 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, with a maximum of 4 tablets in a day.
It's important to note that this medication is not recommended for children under 6 years old. Always follow these guidelines to ensure your child's safety and well-being.
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 always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.
Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.
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 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 complete list of medications and any health conditions you have to receive the best care possible.
Storage and Handling
To ensure the best quality and safety of your product, store it at room temperature, ideally around 25°C (77°F). It can safely be kept within a range of 15°-30°C (59°-86°F). Always check the outer package before use; if it is opened or if the blister is torn or broken, do not use the product. Additionally, make sure to look at the end flap for important information like the expiration date and lot number, which help confirm the product's safety and effectiveness.
Additional Information
You should follow these guidelines for taking the medication safely. For adults and children aged 12 years and older, the recommended dose is 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 dose is 1 tablet every 4 to 6 hours, not exceeding 4 tablets in 24 hours. It’s important to avoid giving this medication to children under 6 years of age. Always adhere to these dosing instructions to ensure safe and effective use.
FAQ
What is QC® (Quality Choice)?
QC® is a maximum strength, non-drowsy nasal decongestant containing 30 mg of pseudoephedrine HCl, available in a pack of 48 tablets.
What does QC® temporarily relieve?
QC® 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?
Adults and children 12 years and over 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.
Is QC® safe for children under 6 years?
No, QC® should not be used in children under 6 years of age.
What should I do if I experience side effects?
Stop using QC® and ask a doctor if you experience nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days or occur with fever.
Are there any warnings associated with QC®?
Do not use QC® if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor or pharmacist if unsure.
What should I do in case of overdose?
In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.
What are the storage conditions for QC®?
Store QC® at 25°C (77°F), with permitted excursions between 15°-30°C (59°-86°F).
Is QC® safe to use during pregnancy or breastfeeding?
If you are pregnant or breastfeeding, ask a health professional before using QC®.
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
No description information is available for the drug.
Uses and Indications
This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies. Additionally, it provides temporary relief from sinus congestion and pressure.
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
Adults and children aged 12 years and over are instructed to take 2 tablets every 4 to 6 hours as needed. The maximum allowable dosage is 8 tablets within a 24-hour period.
For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours, with a maximum of 4 tablets in a 24-hour period.
This medication is not recommended for use in children under 6 years of age.
Contraindications
Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.
Exceeding the recommended dosage while using this product is also contraindicated.
Warnings and Precautions
The use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for a period of two weeks following the discontinuation of an MAOI. Patients uncertain about whether their prescription includes an MAOI are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.
Healthcare professionals should exercise caution and recommend that patients seek medical advice before using this product if they have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to prostate gland enlargement.
In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.
Patients are advised 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 fever, medical advice should be sought promptly.
Side Effects
Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, medical advice should be sought.
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. Furthermore, it should not be used for 2 weeks following the cessation of an MAOI. Patients uncertain about whether their prescription medication contains an MAOI are advised to consult a doctor or pharmacist prior to using this product.
Drug Interactions
There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.
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 12 years and older are recommended to take 2 tablets every 4 to 6 hours, with a maximum dosage of 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, not exceeding 4 tablets in a 24-hour period. The use of this medication is not advised for children under 6 years of age.
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. It is advisable to monitor these patients closely for any 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. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.
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 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 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. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.
Prompt intervention is crucial, as the symptoms of an overdose can vary significantly depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented as soon as possible to mitigate potential risks to the patient’s health.
Nonclinical Toxicology
If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.
Postmarketing Experience
No specific postmarketing experience details have been reported. As such, there are currently no additional adverse events or rare case reports available for review.
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 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 also be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult their doctor or pharmacist.
Patients should be instructed to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and seek medical advice if their symptoms do not improve within seven days or if they experience symptoms accompanied by fever.
It is important to emphasize to patients the necessity of adhering to the recommended dosage and not exceeding it. Healthcare providers should also recommend that patients consult a doctor prior to use if they have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating 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. The recommended storage temperature is 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). Healthcare professionals are advised to check the end flap of the package for the expiration date and lot number to ensure product integrity and safety.
Additional Clinical Information
Patients are advised on the appropriate route, method, and frequency of administration for the medication. Adults and children aged 12 years and over should 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 experience.
Drug Information (PDF)
This file contains official product information for Nasal Decongestant, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.