Quick answers
- What is Naproxen and pseudoephedrine used for?
- The Drug Facts label of Leader All Day Sinus and Cold D (Cardinal Health 110, LLC. dba Leader) lists these uses: temporarily relieves these cold, sinus, and flu symptoms; sinus pressure; minor body aches and pains; headache; nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose); fever.
- Do I need a prescription for Naproxen and pseudoephedrine?
- No. The products on this page are sold without a prescription (over the counter).
- Is a store brand the same as the name brand?
- Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
- Has Naproxen and pseudoephedrine been recalled?
- No recall linked to these products appears in the FDA enforcement reports we use.
Drug Facts label
Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.
Leader All Day Sinus and Cold D · Cardinal Health 110, LLC. dba Leader
Naproxen sodium 220 mg · Pseudoephedrine hydrochloride 120 mg, tablet, film coated, extended release (oral)
Active ingredient (in each caplet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* Pseudoephedrine HCl 120 mg, extended-release *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer Nasal decongestant
Uses
temporarily relieves these cold, sinus, and flu symptoms:
- sinus pressure
- minor body aches and pains
- headache
- nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)
- fever
Warnings
- Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters If an allergic reaction occurs, stop use and seek medical help right away.
- Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
- Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
- if you are now 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 you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- in children under 12 years of age
Ask a doctor before use if
- the stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
- you are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if
you are
- under a doctor’s care for any serious condition
- taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- redness or swelling is present in the painful area
- any new symptoms appear
- fever gets worse or lasts more than 3 days
- you have difficulty swallowing or the caplet feels stuck in your throat
- you get nervous, dizzy, or sleepless
- nasal congestion lasts more than 7 days
If pregnant or breast-feeding
ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- do not take more than directed
- the smallest effective dose should be used
- swallow whole; do not crush or chew
- drink a full glass of water with each dose
- adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours
- children under 12 years: do not use
Inactive ingredients
colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
Questions?
1-800-719-9260
— FDA label of Leader All Day Sinus and Cold D, Cardinal Health 110, LLC. dba Leader, effective April 25, 2025. See the official label on DailyMed →
Mucinex DS 12HR COLD, FEVER and SINUS · Reckitt Benckiser LLC
Naproxen sodium 220 mg · Pseudoephedrine hydrochloride 120 mg, tablet, extended release (oral)
Active ingredient (in each extended-release tablet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) Pseudoephedrine HCl 120 mg,
Purpose
(in each extended-release tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*........Pain reliever/fever reducer Pseudoephedrine HCl 120 mg, extended-release..................................Nasal decongestant *nonsteroidal anti-inflammatory drug
Uses
temporarily relieves these cold, sinus, and flu symptoms:
- sinus pressure
- minor body aches and pains
- headache
- nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)
- fever
Warnings
- Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters If an allergic reaction occurs, stop use and seek medical help right away.
- Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
- Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
- if you are now 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 you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- in children under 12 years of age
Ask a doctor before use if
- the stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
- you are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if
you are
- under a doctor’s care for any serious condition
- taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- redness or swelling is present in the painful area
- any new symptoms appear
- fever gets worse or lasts more than 3 days
- you have difficulty swallowing or the extended-release tablet feels stuck in your throat
- you get nervous, dizzy, or sleepless
- nasal congestion lasts more than 7 days
If pregnant or breast-feeding
ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
- the smallest effective dose should be used
- swallow whole ; do not crush or chew
- drink a full glass of water with each dose
- adults and children 12 years and older: 1 extended-release tablet every 12 hours ; do not take more than 2 extended-release tablets in 24 hours
- children under 12 years: do not use
Other information
- each extended-release tablet contains : sodium 21 mg
- FDA approved dissolution specification differs from the USP dissolution specification
- store at 20-25°C (68-77°F)
- store in a dry place
Inactive ingredients
colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
Questions?
1-866-MUCINEX (1-866-682-4639)
— FDA label of Mucinex DS 12HR COLD, FEVER and SINUS, Reckitt Benckiser LLC, effective May 12, 2026. See the official label on DailyMed →
Aleve-D Sinus and Headache · Bayer HealthCare LLC.
Naproxen sodium 220 mg · Pseudoephedrine hydrochloride 120 mg, tablet (oral)
Active ingredient (in each caplet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* Pseudoephedrine HCl 120 mg, *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer Nasal decongestant
Uses
temporarily relieves these cold, sinus, and flu symptoms:
- sinus pressure
- minor body aches and pains
- headache
- nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)
- fever
Warnings
Allergy alert : Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning : This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed Heart attack and stroke warning : NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
- if you are now 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 you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- in children under 12 years of age
Ask a doctor before use if
- the stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease,asthma
- thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland or had a stroke
- you are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if
you are
- under a doctor’s care for any serious condition
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- redness or swelling is present in the painful area
- any new symptoms appear
- fever gets worse or lasts more than 3 days
- you have difficulty swallowing or the caplet feels stuck in your throat
- you get nervous, dizzy, or sleepless
- nasal congestion lasts more than 7 days
If pregnant or breast-feeding
ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
- the smallest effective dose should be used
- swallow whole ; do not crush or chew
- drink a full glass of water with each dose
- adults and children 12 years and older: 1 caplet every 12 hours ; do not take more than 2 caplets in 24 hours
- children under 12 years: do not use
Other information
Other information
- each caplet contains : sodium 21 mg
- store at 20-25°C (68-77°F)
- store in a dry place
Inactive ingredients
colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
Questions?
1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
— FDA label of Aleve-D Sinus and Headache, Bayer HealthCare LLC., effective December 4, 2025. See the official label on DailyMed →
Sudafed Sinus 12 Hour Pressure plus Pain · Kenvue Brands LLC
Naproxen sodium 220 mg · Pseudoephedrine hydrochloride 120 mg, tablet, multilayer, extended release (oral)
Active ingredient (in each caplet)
Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) nonsteroidal anti-inflammatory drug Pain reliever/fever reducer Pseudoephedrine HCl 120 mg, extended-release Nasal decongestant
Purpose
Active ingredients (in each caplet) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) nonsteroidal anti-inflammatory drug Pain reliever/fever reducer Pseudoephedrine HCl 120 mg, extended-release Nasal decongestant
Uses
temporarily relieves these cold, sinus, and flu symptoms: sinus pressure minor body aches and pains headache nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) fever
Warnings
Allergy alert Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery if you are now 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 you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. in children under 12 years of age
Ask a doctor before use if
the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if
you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin taking any other drug
When using this product
take with food or milk if stomach upset occurs
Stop use and ask a doctor if
you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling redness or swelling is present in the painful area any new symptoms appear fever gets worse or lasts more than 3 days you have difficulty swallowing or the caplet feels stuck in your throat you get nervous, dizzy, or sleepless nasal congestion lasts more than 7 days
If pregnant or breast-feeding
ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
do not take more than directed the smallest effective dose should be used swallow whole; do not crush or chew drink a full glass of water with each dose
| adults and children 12 years and older |
|
| children under 12 years |
|
Inactive ingredients
colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
Questions?
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
— FDA label of Sudafed Sinus 12 Hour Pressure plus Pain, Kenvue Brands LLC, effective November 8, 2024. See the official label on DailyMed →
This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.
Same medicine, other brands
Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.
Naproxen sodium 220 mg · Pseudoephedrine hydrochloride 120 mg · tablet, film coated, extended release (oral) · 5 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| All Day Sinus and Cold D | Walgreen Company | DailyMed |
| Leader All Day Sinus and Cold D | Cardinal Health 110, LLC. dba Leader | DailyMed |
| Sinus and Cold D | Cvs Woonsocket Prescription Center, Incorporated | — |
| Sinus and Cold D | Meijer Distribution Inc | DailyMed |
| Topcare Sinus and Cold D | Topco Associates LLC | DailyMed |
Naproxen sodium 220 mg · Pseudoephedrine hydrochloride 120 mg · tablet, extended release (oral) · 4 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Mucinex DS 12HR COLD, FEVER and SINUS | Reckitt Benckiser LLC | DailyMed |
| Naproxen Sodium and Pseudoephedrine Hydrochloride Cold and Sinus | Vespyr Brands LLC | DailyMed |
| Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold | Aurohealth LLC | DailyMed |
| Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache | Aurohealth LLC | DailyMed |
Naproxen sodium 220 mg · Pseudoephedrine hydrochloride 120 mg · tablet (oral) · 2 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Aleve-D Sinus and Cold | Bayer HealthCare LLC. | DailyMed |
| Aleve-D Sinus and Headache | Bayer HealthCare LLC. | DailyMed |
Naproxen sodium 220 mg · Pseudoephedrine hydrochloride 120 mg · tablet, multilayer, extended release (oral) · 1 product
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Sudafed Sinus 12 Hour Pressure plus Pain | Kenvue Brands LLC | DailyMed |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| naproxen sodium 220 mg · pseudoephedrine hydrochloride 120 mg tablet, film coated, extended release | Generic | $0.2443 per tablet |
NADAC list of November 4, 2026; these prices took effect on May 20, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that sell this medicine
The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.
- Bayer HealthCare LLC.2 products
- Aurohealth LLC2 products
- Vespyr Brands LLC1 product
- Kenvue Brands LLC1 product
- Topco Associates LLC1 product
- Reckitt Benckiser LLC1 product
- Cardinal Health 110, LLC. dba Leader1 product
- Cvs Woonsocket Prescription Center, Incorporated1 product
- Walgreen Company1 product
- Meijer Distribution Inc1 product
Recalls
No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- FDA rule for the Drug Facts label (21 CFR 201.66)
Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.