Pseudoephedrine hydrochloride

Last content change Mar 10, 2026checked dailysee data sync status

Active ingredient: Pseudoephedrine Hydrochloride 15 mg/5 mL – 240 mg
Reference brand: Nasal Decongestant
Drug class: alpha-Adrenergic Agonist
Dosage forms: Capsule, Gelatin Coated
Solution
Tablet
Tablet, Extended Release
Tablet, Film Coated
Tablet, Film Coated, Extended Release
Route: Oral
Prescription status: OTC (over the counter)
Marketed in the U.S.: Since 1981
Label revision date: March 10, 2026
Pregnancy: See Pregnancy Use Section
Lactation: See Lactation Use Section

Active ingredient: Pseudoephedrine Hydrochloride 15 mg/5 mL – 240 mg
Reference brand: Nasal Decongestant
Drug class: alpha-Adrenergic Agonist
Dosage forms: Capsule, Gelatin Coated
Solution
Tablet
Tablet, Extended Release
Tablet, Film Coated
Tablet, Film Coated, Extended Release
Route: Oral
Prescription status: OTC (over the counter)
CSA schedule: Not a scheduled drug
Marketed in the U.S.: Since 1981
Label revision date: March 10, 2026
Pregnancy: See Pregnancy Use Section
Lactation: See Lactation Use Section

Product Labels (88)

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 is a long-acting nasal decongestant available in extended-release tablet form, typically in a dosage of 120 mg. It is designed to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. Additionally, it helps alleviate sinus congestion and pressure, promoting easier breathing through the nose.

This medication is non-drowsy and provides relief for up to 12 hours, making it a convenient option for those experiencing sinus pressure and congestion. Pseudoephedrine Hydrochloride is often compared to the active ingredient in Sudafed® and is available in various packaging options, including coated caplets.

Uses

You can use this medication to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. It also helps alleviate sinus congestion and pressure, making it easier for you to breathe through your nose. Additionally, it promotes nasal and sinus drainage, providing further relief from discomfort associated with congestion.

Dosage and Administration

For adults and children aged 12 years and older, you can take 1 tablet of Pseudoephedrine Hydrochloride every 12 hours, but do not exceed 2 tablets in a 24-hour period. Alternatively, if you are using a different formulation, you may take 2 tablets every 4 to 6 hours, with a maximum of 8 tablets in 24 hours.

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. However, for children under 6 years, this product should not be used. Always ensure to follow the specific instructions on the label for the product you are using.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, or if you have stopped taking an MAOI within the last two weeks. If you are unsure whether your prescription contains an MAOI, please consult your doctor or pharmacist before using this product. Additionally, do not exceed the recommended dosage while using this product.

Side Effects

You should be aware of several potential side effects when using Pseudoephedrine Hydrochloride, a common nasal decongestant. If you experience nervousness, dizziness, or sleeplessness, it's important to stop using the medication and consult a doctor. Additionally, if your symptoms do not improve within 7 days or if you develop a fever, seek medical advice.

Before using this medication, consult 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. Do not use Pseudoephedrine if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression or other psychiatric conditions, or if you have stopped taking an MAOI within the last two weeks. In case of overdose, seek immediate medical help or contact a Poison Control Center.

Warnings and Precautions

Do not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications for depression, psychiatric conditions, or Parkinson's disease, or if you have stopped taking an MAOI within the last 2 weeks. If you are unsure whether your medication contains an MAOI, consult your doctor or pharmacist.
Before using this product, ask your doctor if you have:
- Heart disease
- High blood pressure
- Thyroid disease
- Diabetes
- Trouble urinating due to an enlarged prostate gland
When using this product:
- Do not exceed the recommended dosage.
Stop use and call your doctor if:
- You experience nervousness, dizziness, or sleeplessness.
- Your symptoms do not improve within 7 days or are accompanied by a fever.
In case of overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.
Keep out of reach of children. If you are pregnant or breastfeeding, consult a health professional before use.

Overdose

In the event of an overdose of pseudoephedrine hydrochloride or any nasal decongestant, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Signs of an overdose may include symptoms such as increased heart rate, restlessness, or difficulty breathing. If you suspect an overdose, do not wait for symptoms to appear; act quickly to ensure safety.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult a health professional before using any medications containing pseudoephedrine hydrochloride, which is commonly found in various nasal decongestants. This includes forms such as tablets, film-coated tablets, and extended-release tablets. Seeking guidance from a healthcare provider ensures that you receive safe and appropriate care during this sensitive time.

Always prioritize your health and the health of your baby by discussing any medications you plan to take with your doctor or pharmacist.

Lactation Use

If you are pregnant or breastfeeding, it is important to consult a health professional before using any medications, including nasal decongestants like pseudoephedrine. This is because certain substances can pass into breast milk, potentially affecting your baby. Always prioritize your health and your baby's well-being by seeking guidance from a healthcare provider.

Pediatric Use

You should be aware that many nasal decongestants are not recommended for children under 12 years of age. For children aged 6 to 11 years, the typical dosage is 1 tablet every 4 to 6 hours, with a maximum of 4 tablets in 24 hours. For children aged 12 years and older, the dosage varies: some products recommend taking 1 tablet every 12 hours (up to 2 tablets in 24 hours), while others suggest 2 tablets every 4 to 6 hours (not exceeding 8 tablets in 24 hours).

Always keep these medications out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

You may find that many nasal decongestants, including Pseudoephedrine Hydrochloride and its various formulations (like extended-release tablets), do not provide specific information regarding their use in older adults. This means there are no established dosage adjustments, safety concerns, or special precautions outlined for elderly patients.

As always, it's important to consult with your healthcare provider before starting any new medication, especially if you have underlying health conditions or are taking other medications. They can help ensure that the chosen treatment is safe and appropriate for your individual health needs.

Renal Impairment

When using medications like pseudoephedrine, it's important to be aware of how kidney health can affect your treatment. If you have renal impairment, you may need a lower dose of the medication, and adjustments should be based on your creatinine clearance levels, which is a measure of kidney function. Regular monitoring of your renal function is recommended to ensure your kidneys are handling the medication properly, especially if you have moderate to severe kidney issues.

Always consult your doctor before starting any new medication, particularly if you have kidney problems or if you experience difficulty urinating, as this could indicate other health concerns.

Hepatic Impairment

If you have liver problems, it's important to be aware that some medications may require special attention. For Pseudoephedrine Hydrochloride and related nasal decongestants, dosage adjustments may be necessary, and monitoring of liver function tests is recommended. Caution should be exercised when using these medications if you have liver dysfunction.

For most other products listed, there is no specific information regarding liver impairment, dosage adjustments, or monitoring. Always consult your healthcare provider before starting any new medication, especially if you have existing liver issues.

Drug Interactions

If you are taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, you should not use pseudoephedrine, a common nasal decongestant, while on the medication or for two weeks after stopping it. This combination can lead to serious health risks, including severe hypertension (high blood pressure). It's crucial to discuss all medications and treatments with your healthcare provider to ensure your safety and avoid harmful interactions. If you're unsure whether your medication contains an MAOI, consult your doctor or pharmacist for guidance.

Storage and Handling

To ensure the effectiveness and safety of your Pseudoephedrine Hydrochloride tablets, store them in a dry place at a temperature between 20°C to 25°C (68°F to 77°F). It's important to protect them from light and avoid exposing them to temperatures outside the range of 15°C to 30°C (59°F to 86°F). Always check the packaging for any signs of tampering, such as torn or broken blister units, and do not use the product if any tampering is evident.

When disposing of the product, follow local regulations for medication disposal. If the blister pack is damaged or if the product is past its expiration date, it is best to discard it safely. Always refer to the packaging for specific disposal instructions and expiration details.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion due to the common cold, hay fever, or other upper respiratory allergies. It also temporarily relieves sinus congestion and pressure. Additionally, it promotes nasal and/or sinus drainage and temporarily restores freer breathing through the nose.

Limitations of Use

No teratogenic or nonteratogenic effects have been mentioned in the available data.

Dosage and Administration

Adults and children 12 years and older are recommended to take 1 tablet of Pseudoephedrine Hydrochloride every 12 hours, with a maximum of 2 tablets in a 24-hour period. Alternatively, for certain formulations, adults and children 12 years and older may take 2 tablets every 4 to 6 hours, not exceeding 8 tablets in 24 hours.

For children ages 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours, with a maximum of 4 tablets in 24 hours. Children under 6 years of age should not use this product.

When using extended-release formulations, it is important to swallow the tablet whole with water and not to divide, crush, chew, or dissolve it. The tablet may not completely dissolve and could be visible in the stool, which is a normal occurrence.

Healthcare professionals should advise patients to adhere strictly to the recommended dosages and to consult a doctor if symptoms persist or if there are any questions regarding the use of this medication in children under 12 years of age.

Contraindications

Do not use if the patient is currently taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If there is uncertainty regarding whether a prescription drug contains an MAOI, the patient should consult a doctor or pharmacist before taking this product.

Warnings and Precautions

Do Not Use Do not use if currently taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If unsure whether a prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.

General Precautions Before use, consult a doctor if the individual has:

Heart disease
High blood pressure
Thyroid disease
Diabetes
Trouble urinating due to an enlarged prostate gland

Dosage and Administration When using this product, do not exceed the recommended dosage.

Stop Use and Consult a Doctor Stop use and consult a doctor if:

Nervousness, dizziness, or sleeplessness occurs
Symptoms do not improve within 7 days or occur with a fever
Persistent abdominal pain or vomiting is experienced

Pregnancy and Breastfeeding If pregnant or breastfeeding, consult a health professional before use.

Emergency Medical Help In case of overdose, seek medical help or contact a Poison Control Center immediately (1-800-222-1222).

Keep Out of Reach of Children This product should be kept out of reach of children.

Side Effects

Patients using Pseudoephedrine Hydrochloride may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Serious Warnings

Monoamine Oxidase Inhibitors (MAOIs): Patients should not use Pseudoephedrine if they are currently taking a prescription MAOI (used for depression, psychiatric or emotional conditions, or Parkinson's disease) or within 2 weeks after stopping such medication. If unsure whether their prescription contains an MAOI, patients are advised to consult a doctor or pharmacist.

Common Adverse Reactions

Patients should stop using the medication and consult a doctor if they experience:

Nervousness
Dizziness
Sleeplessness
Symptoms that do not improve within 7 days or occur with a fever

Additional Considerations

Patients should seek medical advice before using Pseudoephedrine if they have:

Heart disease
High blood pressure
Thyroid disease
Diabetes
Trouble urinating due to an enlarged prostate gland

Overdose Information

In the event of an overdose, patients should seek immediate medical help or contact a Poison Control Center.

Rare but Serious Reactions

Bowel Obstruction: Rarely, Pseudoephedrine may cause bowel obstruction, particularly in individuals with severe narrowing of the bowel (esophagus, stomach, or intestine).

Summary

Patients are encouraged to monitor their symptoms closely and consult healthcare professionals if they have any concerns regarding the use of Pseudoephedrine Hydrochloride, especially if they have pre-existing health conditions or are taking other medications.

Drug Interactions

Pseudoephedrine, commonly found in various formulations such as tablets and extended-release forms, is contraindicated in patients currently taking prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing an MAOI. The combination of pseudoephedrine with MAOIs may lead to serious interactions, including the risk of severe hypertension.

This warning is consistent across multiple product labels, emphasizing the importance of avoiding pseudoephedrine in these circumstances. Patients are advised to consult with a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

No additional drug interactions or laboratory test interactions have been reported for pseudoephedrine in the available data.

Pediatric Use

Children under 12 years should not use this product. For children ages 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours, with a maximum of 4 tablets in 24 hours. For children 12 years and older, the dosage is 2 tablets every 4 to 6 hours, not to exceed 8 tablets in 24 hours.

In cases of overdose, medical help should be sought immediately, and the product should be kept out of reach of children.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided in the drug inserts for Pseudoephedrine Hydrochloride and its various formulations, including tablets, film-coated tablets, and extended-release forms. This lack of data suggests that healthcare professionals should exercise caution when prescribing these medications to geriatric patients, considering the potential for increased sensitivity to side effects and the presence of comorbidities that may affect drug metabolism and clearance. Regular monitoring of therapeutic response and adverse effects is recommended for elderly patients receiving these medications.

Pregnancy

Pregnant patients should consult a healthcare professional before using any formulations containing pseudoephedrine hydrochloride, including tablets, film-coated tablets, and extended-release forms. The available data consistently advises that if a patient is pregnant or breastfeeding, they should seek medical advice prior to use.

While specific risk categories or fetal impacts are not detailed in the provided information, the general recommendation emphasizes caution. Healthcare providers are encouraged to evaluate the potential benefits against any risks when considering the use of these medications in pregnant patients.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any products containing pseudoephedrine hydrochloride or similar nasal decongestants. This recommendation applies to all forms, including tablets, film-coated tablets, and extended-release formulations.

While specific data on the excretion of pseudoephedrine in breast milk is not provided, caution is warranted due to the potential effects on breastfed infants. The safety of these medications during lactation has not been fully established, and the risk of adverse effects in infants should be considered.

Healthcare providers should evaluate the necessity of treatment against potential risks when prescribing these medications to lactating mothers.

Renal Impairment

Patients with renal impairment may require careful consideration when using medications containing pseudoephedrine. For these patients, dosage adjustments are often necessary, particularly based on creatinine clearance levels. It is recommended that renal function tests be conducted prior to initiating therapy and monitored regularly thereafter to ensure kidney health.

Specifically, patients with moderate to severe renal impairment may need reduced doses to avoid potential toxicity. Special monitoring is advised for these individuals to mitigate risks associated with their condition. Overall, while some formulations do not provide specific guidance regarding renal impairment, the available data suggests that healthcare providers should exercise caution and tailor treatment plans accordingly for patients with compromised kidney function.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments when using Pseudoephedrine Hydrochloride and related formulations. It is recommended that liver function tests be monitored closely in these patients. Caution should be exercised when administering the drug to individuals with liver dysfunction, as the lack of specific information regarding dosage adjustments and monitoring in the product inserts suggests a need for careful consideration of the patient's hepatic status.

Overdosage

In the event of an overdose involving Pseudoephedrine Hydrochloride or related nasal decongestants, immediate medical assistance should be sought. It is recommended to contact a Poison Control Center without delay at 1-800-222-1222.

Symptoms of overdose may include, but are not limited to, increased heart rate, elevated blood pressure, and potential central nervous system stimulation. Monitoring of vital signs and supportive care may be necessary, depending on the severity of the symptoms presented.

Healthcare professionals should be prepared to provide symptomatic treatment and supportive measures as required. It is crucial to assess the patient's condition and history to determine the appropriate course of action.

Nonclinical Toxicology

Teratogenic Effects

No teratogenic effects were observed in animal studies involving pseudoephedrine hydrochloride. However, it is advised that individuals who are pregnant or breastfeeding consult a healthcare professional before use.

Non-Teratogenic Effects

Animal studies have not indicated an increase in fetal malformations associated with pseudoephedrine. Additionally, no specific non-teratogenic effects have been detailed in the available data. Rarely, the use of pseudoephedrine may lead to bowel obstruction in individuals with severe narrowing of the bowel.

Nonclinical Toxicology

The nonclinical toxicology section lacks specific details across various labels. However, studies in animals have shown that pseudoephedrine does not cause adverse developmental outcomes and is not associated with significant toxic effects at effective doses for decongestion.

Animal Pharmacology and Toxicology

No specific animal pharmacology and toxicology details have been provided in the available data. Overall, the information suggests that pseudoephedrine hydrochloride does not present significant toxicological concerns in animal studies.

Storage and Handling

Pseudoephedrine Hydrochloride is available in various forms, including tablets, film-coated tablets, and extended-release tablets. The product should be stored in a dry place at temperatures between 20° to 25°C (68° to 77°F) or 59° to 77°F, depending on the specific formulation. It is essential to protect the product from light.

Tamper-evident packaging is utilized; therefore, the product should not be used if the blister units are torn, broken, or show any signs of tampering. Additionally, for certain formulations, it is advised to check the carton end panel for the lot number and expiration date.

For products stored at 25°C (77°F), excursions are permitted between 15°-30°C (59°-86°F).

Product Labels

The table below lists all over-the-counter labels containing pseudoephedrine hydrochloride. Use it to compare dosage forms, strengths, and uses across products.

FDA-Approved Pseudoephedrine hydrochloride Labels (Originator & Generics) showing branded and generic formulations with forms, routes, strengths, and FDA approval years.

12 Hour Nasal Decongestant CARDINAL HEALTH	Tablet, Film Coated	Oral	120 mg	2024
Label 12 Hour Nasal DecongestantView full label details → Manufacturer CARDINAL HEALTH Form Tablet, Film Coated Routes Oral Strength range 120 mg FDA year 2024 Indications nasal congestion sinus congestion
12 Hour Nasal Decongestant CVS Pharmacy	Tablet, Film Coated, Extended Release	Oral	120 mg	1999
Label 12 Hour Nasal DecongestantView full label details → Manufacturer CVS Pharmacy Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 1999 Indications nasal congestion sinus congestion
Careone Nasal and Sinus Decongestant American Sales Company	Tablet, Film Coated	Oral	30 mg	2017
Label Careone Nasal and Sinus DecongestantView full label details → Manufacturer American Sales Company Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 2017 Indications common cold relief hay fever relief nasal congestion relief sinus congestion relief upper respiratory allergies relief
Careone Nasal and Sinus Decongestant American Sales Company	Tablet, Film Coated, Extended Release	Oral	120 mg	2016
Label Careone Nasal and Sinus DecongestantView full label details → Manufacturer American Sales Company Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2016 Indications nasal congestion sinus congestion
Childrens Sudafed Kenvue Brands LLC	Solution	Oral	15 mg/5 mL	2008
Label Childrens SudafedView full label details → Manufacturer Kenvue Brands LLC Form Solution Routes Oral Strength range 15 mg/5 mL FDA year 2008 Indications nasal congestion nasal drainage sinus congestion sinus drainage sinus pressure
Equaline 12 Hour Decongestant United Natural Foods, Inc. dba UNFI	Tablet, Film Coated, Extended Release	Oral	120 mg	2004
Label Equaline 12 Hour DecongestantView full label details → Manufacturer United Natural Foods, Inc. dba UNFI Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2004 Indications nasal congestion sinus congestion
Equaline Nasal Decongestant United Natural Foods, Inc. dba UNFI	Tablet, Film Coated	Oral	30 mg	2004
Label Equaline Nasal DecongestantView full label details → Manufacturer United Natural Foods, Inc. dba UNFI Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 2004 Indications common cold relief hay fever relief nasal congestion relief sinus congestion relief upper respiratory allergies relief
Equate Sinus 12 Hour Wal-Mart Stores Inc	Tablet, Film Coated, Extended Release	Oral	120 mg	2020
Label Equate Sinus 12 HourView full label details → Manufacturer Wal-Mart Stores Inc Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2020 Indications nasal congestion sinus congestion
Good Neighbor Pharmacy Nasal Decongestant Amerisource Bergen	Tablet, Film Coated, Extended Release	Oral	120 mg	1999
Label Good Neighbor Pharmacy Nasal DecongestantView full label details → Manufacturer Amerisource Bergen Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 1999 Indications nasal congestion sinus congestion
Good Sense Nasal Decongestant L. Perrigo Company	Tablet, Film Coated	Oral	30 mg	1989
Label Good Sense Nasal DecongestantView full label details → Manufacturer L. Perrigo Company Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1989 Indications common cold relief hay fever relief nasal congestion relief sinus congestion relief upper respiratory allergies relief
Good Sense Suphedrine L. Perrigo Company	Tablet, Film Coated, Extended Release	Oral	120 mg	1999
Label Good Sense SuphedrineView full label details → Manufacturer L. Perrigo Company Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 1999 Indications nasal congestion sinus congestion
Leader 12 Hour Nasal Decongestant Cardinal Health 110, LLC. dba Leader	Tablet, Film Coated, Extended Release	Oral	120 mg	2019
Label Leader 12 Hour Nasal DecongestantView full label details → Manufacturer Cardinal Health 110, LLC. dba Leader Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2019 Indications nasal congestion sinus congestion
Leader 12 Hour Sinus Nasal Decongestant Cardinal Health 110, LLC. dba Leader	Tablet, Film Coated, Extended Release	Oral	120 mg	2025
Label Leader 12 Hour Sinus Nasal DecongestantView full label details → Manufacturer Cardinal Health 110, LLC. dba Leader Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2025 Indications nasal congestion sinus congestion
Leader Nasal Decongestant Cardinal Health 110, LLC. dba Leader	Tablet, Film Coated	Oral	30 mg	2019
Label Leader Nasal DecongestantView full label details → Manufacturer Cardinal Health 110, LLC. dba Leader Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 2019 Indications common cold relief hay fever relief nasal congestion relief sinus congestion relief upper respiratory allergies relief
Nasal Decongestant Amerisource Bergen	Tablet, Film Coated	Oral	30 mg	1981
Label Nasal DecongestantView full label details → Manufacturer Amerisource Bergen Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1981 Indications nasal congestion sinus congestion
Nasal Decongestant Better Living Brands, LLC	Tablet, Film Coated	Oral	30 mg	1981
Label Nasal DecongestantView full label details → Manufacturer Better Living Brands, LLC Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1981 Indications nasal congestion sinus congestion
Nasal Decongestant Chain Drug Consortium	Tablet, Film Coated	Oral	30 mg	1981
Label Nasal DecongestantView full label details → Manufacturer Chain Drug Consortium Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1981 Indications nasal congestion sinus congestion
Nasal Decongestant CHAIN DRUG MARKETING ASSOCIATION INC	Tablet, Film Coated	Oral	30 mg	1981
Label Nasal DecongestantView full label details → Manufacturer CHAIN DRUG MARKETING ASSOCIATION INC Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1981 Indications nasal congestion sinus congestion
Nasal Decongestant CVS Pharmacy	Tablet, Film Coated	Oral	30 mg	1981
Label Nasal DecongestantView full label details → Manufacturer CVS Pharmacy Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1981 Indications nasal congestion sinus congestion
Nasal Decongestant CVS Pharmacy	Tablet, Film Coated	Oral	30 mg	1987
Label Nasal DecongestantView full label details → Manufacturer CVS Pharmacy Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1987 Indications common cold relief hay fever relief nasal congestion relief sinus congestion relief upper respiratory allergies relief
Nasal Decongestant H E B	Tablet, Film Coated	Oral	30 mg	1981
Label Nasal DecongestantView full label details → Manufacturer H E B Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1981 Indications nasal congestion sinus congestion
Nasal Decongestant L. N. K. International, Inc.	Tablet, Film Coated	Oral	30 mg	1981
Label Nasal DecongestantView full label details → Manufacturer L. N. K. International, Inc. Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1981 Indications nasal congestion sinus congestion
Nasal Decongestant Meijer Distribution Inc	Tablet, Film Coated, Extended Release	Oral	120 mg	2018
Label Nasal DecongestantView full label details → Manufacturer Meijer Distribution Inc Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2018 Indications nasal congestion sinus congestion
Nasal Decongestant Meijer Distribution Inc	Tablet, Film Coated	Oral	30 mg	1991
Label Nasal DecongestantView full label details → Manufacturer Meijer Distribution Inc Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1991 Indications common cold relief hay fever relief nasal congestion relief sinus congestion relief upper respiratory allergies relief
Nasal Decongestant Publix Super Markets Inc	Tablet, Film Coated	Oral	30 mg	1993
Label Nasal DecongestantView full label details → Manufacturer Publix Super Markets Inc Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1993 Indications common cold relief hay fever relief nasal congestion relief sinus congestion relief upper respiratory allergies relief
Nasal Decongestant Rugby Laboratories	Tablet	Oral	30 mg	2012
Label Nasal DecongestantView full label details → Manufacturer Rugby Laboratories Form Tablet Routes Oral Strength range 30 mg FDA year 2012 Indications freer breathing nasal congestion
Nasal Decongestant Strategic Sourcing Services	Tablet, Extended Release	Oral	120 mg	2018
Label Nasal DecongestantView full label details → Manufacturer Strategic Sourcing Services Form Tablet, Extended Release Routes Oral Strength range 120 mg FDA year 2018 Indications nasal congestion sinus congestion
Nasal Decongestant Strategic Sourcing Services LLC	Tablet, Film Coated	Oral	30 mg	2023
Label Nasal DecongestantView full label details → Manufacturer Strategic Sourcing Services LLC Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 2023 Indications nasal congestion sinus congestion
Nasal Decongestant Walgreen Company	Tablet, Film Coated	Oral	30 mg	1981
Label Nasal DecongestantView full label details → Manufacturer Walgreen Company Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1981 Indications nasal congestion sinus congestion
Nasal Decongestant D Walgreen Company	Tablet, Film Coated, Extended Release	Oral	120 mg	2022
Label Nasal Decongestant DView full label details → Manufacturer Walgreen Company Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2022 Indications nasal congestion sinus congestion
Pseudoephedrine Hcl Aurohealth LLC	Tablet, Extended Release	Oral	120 mg	2017
Label Pseudoephedrine HclView full label details → Manufacturer Aurohealth LLC Form Tablet, Extended Release Routes Oral Strength range 120 mg FDA year 2017 Indications nasal congestion sinus congestion
Pseudoephedrine Hcl Better Living Brands LLC	Tablet, Extended Release	Oral	120 mg	2023
Label Pseudoephedrine HclView full label details → Manufacturer Better Living Brands LLC Form Tablet, Extended Release Routes Oral Strength range 120 mg FDA year 2023 Indications nasal congestion sinus congestion
Pseudoephedrine Hcl Major Pharmaceuticals	Tablet, Film Coated	Oral	30 mg	2019
Label Pseudoephedrine HclView full label details → Manufacturer Major Pharmaceuticals Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 2019 Indications common cold relief hay fever relief nasal congestion relief sinus congestion relief upper respiratory allergies relief
Pseudoephedrine Hydrochloride Aurohealth LLC	Tablet, Extended Release	Oral	240 mg	2025
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Aurohealth LLC Form Tablet, Extended Release Routes Oral Strength range 240 mg FDA year 2025 Indications nasal congestion nasal passage swelling sinus pressure
Pseudoephedrine Hydrochloride Cardinal Health	Tablet, Extended Release	Oral	120 mg	2017
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Cardinal Health Form Tablet, Extended Release Routes Oral Strength range 120 mg FDA year 2017 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride CARDINAL HEALTH 110, LLC DBA LEADER	Tablet	Oral	120 mg	2022
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer CARDINAL HEALTH 110, LLC DBA LEADER Form Tablet Routes Oral Strength range 120 mg FDA year 2022 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride Chain Drug Consortium, LLC	Tablet, Film Coated, Extended Release	Oral	120 mg	2006
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Chain Drug Consortium, LLC Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2006 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride Chain Drug Marketing Association Inc.	Tablet, Film Coated, Extended Release	Oral	120 mg	2006
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Chain Drug Marketing Association Inc. Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2006 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride CVS Pharmacy	Tablet, Film Coated, Extended Release	Oral	120 mg	2006
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer CVS Pharmacy Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2006 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride DISCOUNT DRUG MART	Tablet, Extended Release	Oral	120 mg	2018
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer DISCOUNT DRUG MART Form Tablet, Extended Release Routes Oral Strength range 120 mg FDA year 2018 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride HEB	Tablet, Extended Release	Oral	120 mg	2019
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer HEB Form Tablet, Extended Release Routes Oral Strength range 120 mg FDA year 2019 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride Major Pharmaceuticals	Tablet, Film Coated	Oral	120 mg	2024
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Major Pharmaceuticals Form Tablet, Film Coated Routes Oral Strength range 120 mg FDA year 2024 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride Major Pharmaceuticals	Tablet	Oral	30 mg	2019
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Major Pharmaceuticals Form Tablet Routes Oral Strength range 30 mg FDA year 2019 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride Major Pharmaceuticals	Tablet	Oral	60 mg	2019
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Major Pharmaceuticals Form Tablet Routes Oral Strength range 60 mg FDA year 2019 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride Meijer Distribution, Inc.	Tablet, Film Coated, Extended Release	Oral	120 mg	2006
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Meijer Distribution, Inc. Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2006 Indications freer breathing nasal congestion allergies nasal congestion common cold nasal congestion hay fever nasal drainage sinus congestion relief
Pseudoephedrine Hydrochloride Ohm Laboratories Inc.	Tablet, Film Coated	Oral	120 mg	2006
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Ohm Laboratories Inc. Form Tablet, Film Coated Routes Oral Strength range 120 mg FDA year 2006 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride Ohm Laboratories Inc.	Tablet, Extended Release	Oral	120 mg	2006
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Ohm Laboratories Inc. Form Tablet, Extended Release Routes Oral Strength range 120 mg FDA year 2006 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride Padagis Israel Pharmaceuticals Ltd	Tablet, Film Coated	Oral	30 mg	2008
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Padagis Israel Pharmaceuticals Ltd Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 2008 Indications common cold relief hay fever relief nasal congestion relief sinus congestion relief upper respiratory allergies relief
Pseudoephedrine Hydrochloride Padagis Israel Pharmaceuticals Ltd	Tablet, Film Coated, Extended Release	Oral	120 mg	2014
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Padagis Israel Pharmaceuticals Ltd Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2014 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride Publix Super Markets Inc	Tablet, Film Coated, Extended Release	Oral	120 mg	2006
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Publix Super Markets Inc Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2006 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride Safeway Inc.	Tablet, Film Coated, Extended Release	Oral	120 mg	2006
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Safeway Inc. Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2006 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride SAM'S WEST INC	Tablet, Film Coated	Oral	120 mg	2012
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer SAM'S WEST INC Form Tablet, Film Coated Routes Oral Strength range 120 mg FDA year 2012 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride Shopko Stores Operating Co. , LLC	Tablet, Film Coated, Extended Release	Oral	120 mg	2006
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Shopko Stores Operating Co. , LLC Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2006 Indications freer breathing nasal congestion nasal drainage sinus congestion relief
Pseudoephedrine Hydrochloride Sportpharm LLC	Tablet, Film Coated	Oral	120 mg	2006
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Sportpharm LLC Form Tablet, Film Coated Routes Oral Strength range 120 mg FDA year 2006 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride Sportpharm LLC	Tablet, Film Coated	Oral	30 mg	2008
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Sportpharm LLC Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 2008 Indications nasal congestion due to allergies nasal congestion due to cold nasal congestion due to hay fever nasal congestion relief sinus congestion relief
Pseudoephedrine Hydrochloride STRATEGIC SOURCING SERVICES LLC	Tablet, Film Coated	Oral	120 mg	2023
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer STRATEGIC SOURCING SERVICES LLC Form Tablet, Film Coated Routes Oral Strength range 120 mg FDA year 2023 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride STRATEGIC SOURCING SERVICES LLC	Tablet, Extended Release	Oral	120 mg	2017
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer STRATEGIC SOURCING SERVICES LLC Form Tablet, Extended Release Routes Oral Strength range 120 mg FDA year 2017 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride The Kroger Company	Tablet	Oral	120 mg	2021
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer The Kroger Company Form Tablet Routes Oral Strength range 120 mg FDA year 2021 Indications nasal congestion sinus congestion
Pseudoephedrine Hydrochloride WALGREEN CO.	Tablet, Extended Release	Oral	240 mg	2026
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer WALGREEN CO. Form Tablet, Extended Release Routes Oral Strength range 240 mg FDA year 2026 Indications nasal congestion nasal passage swelling sinus pressure
Pseudoephedrine Hydrochloride Walgreen Company	Tablet, Film Coated, Extended Release	Oral	120 mg	2006
Label Pseudoephedrine HydrochlorideView full label details → Manufacturer Walgreen Company Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2006 Indications nasal congestion sinus congestion
Sinus Kroger Company	Tablet, Film Coated	Oral	30 mg	2020
Label SinusView full label details → Manufacturer Kroger Company Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 2020 Indications common cold relief hay fever relief nasal congestion relief sinus congestion relief upper respiratory allergies relief
Sinus 12 Hour L. Perrigo Company	Tablet, Film Coated, Extended Release	Oral	120 mg	2017
Label Sinus 12 HourView full label details → Manufacturer L. Perrigo Company Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2017 Indications nasal congestion sinus congestion
Sinus and Congestion Wal-Mart Stores Inc	Tablet, Film Coated	Oral	30 mg	2020
Label Sinus and CongestionView full label details → Manufacturer Wal-Mart Stores Inc Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 2020 Indications nasal congestion sinus congestion
Sinus and Nasal Decongestant CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	Tablet, Film Coated	Oral	30 mg	2025
Label Sinus and Nasal DecongestantView full label details → Manufacturer CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 2025 Indications nasal congestion sinus congestion
Sinus and Nasal Decongestant CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	Tablet, Film Coated	Oral	30 mg	2025
Label Sinus and Nasal DecongestantView full label details → Manufacturer CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 2025 Indications allergy relief common cold relief hay fever relief nasal congestion relief sinus congestion relief
Sinus and Nasal Decongestant CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	Tablet, Film Coated, Extended Release	Oral	120 mg	2026
Label Sinus and Nasal DecongestantView full label details → Manufacturer CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2026 Indications nasal congestion sinus congestion
Sinus Congestion Chain Drug Marketing Association, Inc.	Tablet, Film Coated	Oral	30 mg	2025
Label Sinus CongestionView full label details → Manufacturer Chain Drug Marketing Association, Inc. Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 2025 Indications nasal congestion sinus congestion
Sinus Decongestion Kroger Company	Tablet, Film Coated	Oral	30 mg	2021
Label Sinus DecongestionView full label details → Manufacturer Kroger Company Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 2021 Indications nasal congestion sinus congestion
Sinus Pressure and Congestion Relief Rite Aid Corporation	Tablet, Film Coated, Extended Release	Oral	120 mg	1999
Label Sinus Pressure and Congestion ReliefView full label details → Manufacturer Rite Aid Corporation Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 1999 Indications nasal congestion sinus congestion
Sinus Pressure and Congestion Relief Rite Aid Corporation	Tablet, Film Coated	Oral	30 mg	1981
Label Sinus Pressure and Congestion ReliefView full label details → Manufacturer Rite Aid Corporation Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1981 Indications nasal congestion sinus congestion
Sudafed Sinus Congestion Kenvue Brands LLC	Tablet, Film Coated	Oral	30 mg	2021
Label Sudafed Sinus CongestionView full label details → Manufacturer Kenvue Brands LLC Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 2021 Indications allergy relief common cold relief hay fever relief nasal congestion relief sinus congestion relief
Sudafed Sinus Congestion 12 Hour Kenvue Brands LLC	Tablet, Film Coated, Extended Release	Oral	120 mg	2019
Label Sudafed Sinus Congestion 12 HourView full label details → Manufacturer Kenvue Brands LLC Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2019 Indications nasal congestion sinus congestion
Sudogest Major Pharmaceuticals	Tablet, Film Coated	Oral	30 mg	1981
Label SudogestView full label details → Manufacturer Major Pharmaceuticals Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1981 Indications nasal congestion sinus congestion
Sudogest 12 Hour Major Pharmaceuticals	Tablet, Film Coated, Extended Release	Oral	120 mg	2019
Label Sudogest 12 HourView full label details → Manufacturer Major Pharmaceuticals Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2019 Indications nasal congestion sinus congestion
Sudogest Nasal Decongestant Major Pharmaceuticals	Tablet, Film Coated	Oral	30 mg	1991
Label Sudogest Nasal DecongestantView full label details → Manufacturer Major Pharmaceuticals Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1991 Indications common cold relief hay fever relief nasal congestion relief sinus congestion relief upper respiratory allergies relief
Topcare 12 Hour Decongestant Topco Associates LLC	Tablet, Film Coated, Extended Release	Oral	120 mg	2000
Label Topcare 12 Hour DecongestantView full label details → Manufacturer Topco Associates LLC Form Tablet, Film Coated, Extended Release Routes Oral Strength range 120 mg FDA year 2000 Indications nasal congestion sinus congestion
Topcare Nasal Decongestant Topco Associates LLC	Tablet, Film Coated	Oral	30 mg	1988
Label Topcare Nasal DecongestantView full label details → Manufacturer Topco Associates LLC Form Tablet, Film Coated Routes Oral Strength range 30 mg FDA year 1988 Indications common cold relief hay fever relief nasal congestion relief sinus congestion relief upper respiratory allergies relief
Zephrex D L. Perrigo Company	Capsule, Gelatin Coated	Oral	30 mg	2016
Label Zephrex DView full label details → Manufacturer L. Perrigo Company Form Capsule, Gelatin Coated Routes Oral Strength range 30 mg FDA year 2016 Indications nasal congestion sinus congestion

Repacked & Relabeled Product Labels

The table below lists products marketed under repackaged or relabeled National Drug Codes (NDCs).

Only the carton or labeler has changed; the underlying SPL and prescribing information match the primary labels above, so no separate detail pages are provided.

Label

Forms

Routes

Pseudoephedrine Hydrochloride

FDA year

Proficient Rx LP

Tablet

Oral

30 mg

2012

Label: Nasal Decongestant
Manufacturer: Proficient Rx LP
Form: Tablet
Routes: Oral
Strength range: 30 mg
FDA year: 2012

Packaging

Packaging configurations for Nasal Decongestant.
				Details
	1 in carton 24 in blister pack 24 items total	Tablet	30 mg
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Active (as of March 3, 2014) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 30 mg Inactive ingredients croscarmellose sodium FD&C yellow no. 6 magnesium stearate microcrystalline cellulose titanium dioxide calcium sulfate, unspecified form carnauba wax FD&C red no. 40 gelatin, unspecified kaolin anhydrous lactose magnesium silicate shellac silicon dioxide 12-hydroxystearic acid acer saccharum pollen

Rebel Distributors Corp

Tablet, Film Coated, Extended Release

Oral

120 mg

1999

Label: Nasal Decongestant
Manufacturer: Rebel Distributors Corp
Form: Tablet, Film Coated, Extended Release
Routes: Oral
Strength range: 120 mg
FDA year: 1999

Packaging

Packaging configurations for Nasal Decongestant.
				Details
	1 in carton 10 in blister pack 10 items total	Tablet, Film Coated, Extended Release	120 mg
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Not marketed Active ingredients Pseudoephedrine Hydrochloride 120 mg Inactive ingredients carnauba wax silicon dioxide calcium phosphate, dibasic, dihydrate hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycols polysorbate 80 titanium dioxide

A-S Medication Solutions

Tablet, Film Coated

Oral

120 mg

2006

Label: Pseudoephedrine Hydrochloride
Manufacturer: A-S Medication Solutions
Form: Tablet, Film Coated
Routes: Oral
Strength range: 120 mg
FDA year: 2006

Packaging

Packaging configurations for Pseudoephedrine Hydrochloride.
				Details
	10 in blister pack 10 items total	Tablet, Film Coated	120 mg
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Active (as of June 14, 2021) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 120 mg Inactive ingredients ricinus communis (castor) seed oil silica hydroxypropyl methylcellulose magnesium stearate microcrystalline cellulose titanium dioxide

A-S Medication Solutions

Tablet, Film Coated

Oral

30 mg

2008

Label: Pseudoephedrine Hydrochloride
Manufacturer: A-S Medication Solutions
Form: Tablet, Film Coated
Routes: Oral
Strength range: 30 mg
FDA year: 2008

Packaging

Packaging configurations for Pseudoephedrine Hydrochloride.

	48 in carton 1 in blister pack 48 items total	Tablet, Film Coated	30 mg
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Marketing ended (as of November 15, 2021) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 30 mg Inactive ingredients carnauba wax dibasic calcium phosphate dihydrate hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polysorbate 80 silicon dioxide titanium dioxide FD&C red no. 40
	24 in carton 1 in blister pack 24 items total	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: NSDE file: March 12, 2026 → status: Active (as of August 23, 2021) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 30 mg Inactive ingredients carnauba wax dibasic calcium phosphate dihydrate hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polysorbate 80 silicon dioxide titanium dioxide FD&C red no. 40

A-S Medication Solutions

Tablet

Oral

60 mg

2019

Label: Pseudoephedrine Hydrochloride
Manufacturer: A-S Medication Solutions
Form: Tablet
Routes: Oral
Strength range: 60 mg
FDA year: 2019

Packaging

Packaging configurations for Pseudoephedrine Hydrochloride.

	24 in bottle 24 items total	Tablet	60 mg
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Marketing ended (as of April 23, 2025) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 60 mg Inactive ingredients lactose monohydrate croscarmellose sodium silica cellulose, microcrystalline magnesium stearate stearic acid
	30 in bottle 30 items total	Tablet	60 mg
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Active (as of September 20, 2019) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 60 mg Inactive ingredients lactose monohydrate croscarmellose sodium silica cellulose, microcrystalline magnesium stearate stearic acid
	12 in bottle 12 items total	Tablet	60 mg
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Marketing ended (as of April 23, 2025) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 60 mg Inactive ingredients lactose monohydrate croscarmellose sodium silica cellulose, microcrystalline magnesium stearate stearic acid
	20 in bottle 20 items total	Tablet	60 mg
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Marketing ended (as of April 23, 2025) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 60 mg Inactive ingredients lactose monohydrate croscarmellose sodium silica cellulose, microcrystalline magnesium stearate stearic acid
	15 in bottle 15 items total	Tablet	60 mg
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Marketing ended (as of April 23, 2025) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 60 mg Inactive ingredients lactose monohydrate croscarmellose sodium silica cellulose, microcrystalline magnesium stearate stearic acid

Proficient Rx LP

Tablet, Film Coated

Oral

30 mg

2008

Label: Pseudoephedrine Hydrochloride
Manufacturer: Proficient Rx LP
Form: Tablet, Film Coated
Routes: Oral
Strength range: 30 mg
FDA year: 2008

Packaging

Packaging configurations for Pseudoephedrine Hydrochloride.
				Details
	24 in carton 1 in blister pack 24 items total	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: NSDE file: March 12, 2026 → status: Active (as of January 1, 2019) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 30 mg Inactive ingredients carnauba wax dibasic calcium phosphate dihydrate hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polysorbate 80 silicon dioxide titanium dioxide FD&C red no. 40

A-S Medication Solutions

Tablet, Film Coated, Extended Release

Oral

120 mg

2017

Label: Sudafed 12 Hour
Manufacturer: A-S Medication Solutions
Form: Tablet, Film Coated, Extended Release
Routes: Oral
Strength range: 120 mg
FDA year: 2017

Packaging

Packaging configurations for Sudafed 12 Hour.
				Details
	1 in carton 10 in blister pack 10 items total	Tablet, Film Coated, Extended Release	120 mg
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Not marketed Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 120 mg Inactive ingredients carnauba wax silicon dioxide dibasic calcium phosphate dihydrate hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polysorbate 80 titanium dioxide

A-S Medication Solutions

Tablet, Film Coated, Extended Release

Oral

120 mg

2019

Label: Sudafed Sinus Congestion 12 Hour
Manufacturer: A-S Medication Solutions
Form: Tablet, Film Coated, Extended Release
Routes: Oral
Strength range: 120 mg
FDA year: 2019

Packaging

Packaging configurations for Sudafed Sinus Congestion 12 Hour.
				Details
	1 in carton 10 in blister pack 10 items total	Tablet, Film Coated, Extended Release	120 mg
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Active (as of October 21, 2019) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 120 mg Inactive ingredients carnauba wax silica calcium phosphate, dibasic, dihydrate hydroxypropyl methylcellulose magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified PEG-20 sorbitan oleate ci 77891

A-S Medication Solutions

Tablet, Film Coated

Oral

30 mg

1981

Label: Sudogest
Manufacturer: A-S Medication Solutions
Form: Tablet, Film Coated
Routes: Oral
Strength range: 30 mg
FDA year: 1981

Packaging

Packaging configurations for Sudogest.
				Details
	28 in bottle 28 items total	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: NSDE file: March 12, 2026 → status: Active (as of August 19, 2015) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 30 mg Inactive ingredients croscarmellose sodium dibasic calcium phosphate dihydrate FD&C red no. 40 FD&C yellow no. 6 hypromellose, unspecified magnesium stearate microcrystalline cellulose polydextrose polyethylene glycol, unspecified silicon dioxide titanium dioxide triacetin

A-S Medication Solutions

Tablet, Film Coated

Oral

30 mg

1991

Label: Sudogest Nasal Decongestant
Manufacturer: A-S Medication Solutions
Form: Tablet, Film Coated
Routes: Oral
Strength range: 30 mg
FDA year: 1991

Packaging

Packaging configurations for Sudogest Nasal Decongestant.

	48 in bottle 48 items total	Tablet, Film Coated	30 mg
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Marketing ended (as of December 31, 2023) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 30 mg Inactive ingredients copernicia cerifera (carnauba) wax dicalcium phosphate dihydrate hydroxypropyl methylcellulose magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified PEG-20 sorbitan oleate silica ci 77891 curry red
	24 in carton 1 in blister pack 24 items total	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: NSDE file: March 12, 2026 → status: Active (as of June 10, 2019) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 30 mg Inactive ingredients copernicia cerifera (carnauba) wax dicalcium phosphate dihydrate hydroxypropyl methylcellulose magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified PEG-20 sorbitan oleate silica ci 77891 curry red
	12 in bottle 12 items total	Tablet, Film Coated	30 mg
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Marketing ended (as of December 31, 2023) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 30 mg Inactive ingredients copernicia cerifera (carnauba) wax dicalcium phosphate dihydrate hydroxypropyl methylcellulose magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified PEG-20 sorbitan oleate silica ci 77891 curry red
	30 in bottle 30 items total	Tablet, Film Coated	30 mg
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Marketing ended (as of December 31, 2023) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 30 mg Inactive ingredients copernicia cerifera (carnauba) wax dicalcium phosphate dihydrate hydroxypropyl methylcellulose magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified PEG-20 sorbitan oleate silica ci 77891 curry red
	4 in bottle 4 items total	Tablet, Film Coated	30 mg
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Marketing ended (as of December 31, 2023) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 30 mg Inactive ingredients copernicia cerifera (carnauba) wax dicalcium phosphate dihydrate hydroxypropyl methylcellulose magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified PEG-20 sorbitan oleate silica ci 77891 curry red
	15 in bottle 15 items total	Tablet, Film Coated	30 mg
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: March 12, 2026 → status: Marketing ended (as of December 31, 2023) Type Type 0: Not a Combination Product Active ingredients Pseudoephedrine Hydrochloride 30 mg Inactive ingredients copernicia cerifera (carnauba) wax dicalcium phosphate dihydrate hydroxypropyl methylcellulose magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified PEG-20 sorbitan oleate silica ci 77891 curry red

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It consolidates data from 88 FDA Structured Product Labels (DailyMed) for Pseudoephedrine Hydrochloride (marketed as Sudogest Nasal Decongestant, Sudafed Sinus Congestion 12 Hour, 12 Hour Nasal Decongestant), with data retrieved March 13, 2026 by a validated AI data-extraction workflow. This includes 88 distinct product formulations. All FDA-listed dosage forms and strengths are aggregated in the sections above. Regulatory status appears in the Summary Information panel and was verified in the FDA National Drug Code directory. Detailed product-specific information is available via the individual label pages linked above. No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update: March 13, 2026

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.