Aleve-D Sinus and Headache
naproxen sodium, pseudoephedrine hydrochloride · Tablet · Oral
Active ingredient
Active ingredients (in each caplet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* Pseudoephedrine HCl 120 mg, *nonsteroidal anti-inflammatory drug
Purpose
Purposes Pain reliever/fever reducer Nasal decongestant
Uses
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
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
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
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
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
When using this product
• take with food or milk if stomach upset occurs
Stop use and ask a doctor
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
Pregnancy or breast-feeding
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
Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
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
Inactive ingredients colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
Questions?
Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
Label text from the FDA structured product label by Bayer HealthCare LLC. (revised Dec 4, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Naproxen Sodium in 1 product
- Pseudoephedrine Hydrochloride in 1 product
Aleve-D Sinus and Headache NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0280-6045 | Naproxen Sodium 220 mg/1; Pseudoephedrine Hydrochloride 120 mg/1 Tablet | Bayer HealthCare LLC. | ANDA |
Frequently asked questions
What is Aleve-D Sinus and Headache used for?
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
Who makes Aleve-D Sinus and Headache?
Aleve-D Sinus and Headache is listed by 1 labeler in the FDA NDC directory, including Bayer HealthCare LLC..