Approved indications: Aleve-D Sinus and Cold is indicated for the temporary relief of sinus pressure, nasal and sinus congestion (by promoting sinus drainage), headache, minor body aches and pains, and fever associated with colds and flu in adults and children 12 years and older.

Off-label uses: This combination product is mainly used for its labeled cold, sinus, and flu symptoms; clinicians typically do not use it long term or for other conditions, preferring individual ingredients (such as naproxen alone) when different dosing or indications are needed.

Efficacy expectations:

• Symptom relief (less sinus pressure and congestion, reduced headache and body aches, and lowered fever) often begins within about 30–60 minutes after a dose.
• Because naproxen and pseudoephedrine are long-acting in this formulation, improvement commonly lasts up to 12 hours per caplet, so only two doses per day are usually needed.
• Compared with many other over-the-counter cold and sinus products, it offers similar overall symptom relief but with longer dosing intervals (every 12 hours instead of every 4–6 hours).

Typical dosing and how to take it:

• Adults and children 12 years and older: 1 caplet by mouth every 12 hours; do not take more than 2 caplets in 24 hours.
• Do not use in children under 12 years.
• Swallow caplets whole with a full glass of water; do not crush, chew, or split them.
• May be taken with food or milk if stomach upset occurs; use the lowest effective dose for the shortest possible time, and contact a clinician if fever lasts more than 3 days or if symptoms last more than about 7 days or worsen.

Special dosing instructions: Do not take Aleve-D Sinus and Cold with other products that contain naproxen, other NSAIDs (such as ibuprofen or aspirin), or other decongestants or stimulants containing pseudoephedrine or similar ingredients.

Missed dose: If you take it on a schedule and miss a dose, take it as soon as you remember unless it is almost time for the next dose; do not take two doses at once or closer than 12 hours apart.

Overdose: In case of suspected overdose or if too many caplets are taken, seek emergency medical care or contact Poison Control (1-800-222-1222 in the U.S.) right away.

Common side effects:

• Stomach upset, heartburn, nausea, headache, dizziness, or drowsiness from the naproxen component; these are usually mild and improve when the medicine is stopped or taken with food.
• Nervousness, restlessness, increased heart rate, or trouble sleeping from pseudoephedrine, especially if taken near bedtime or with caffeine or other stimulants.

Serious or rare adverse effects (seek immediate medical attention):

• Signs of allergic reaction such as rash, hives, itching, swelling of the face, lips, tongue, or throat, or trouble breathing.
• Stomach or intestinal bleeding or ulcer (fainting, vomiting blood, or black or bloody stools, or severe or persistent stomach pain).
• Chest pain, shortness of breath, sudden weakness on one side, trouble speaking, or leg swelling, which may signal heart attack, heart failure, or stroke.
• Severe rise in blood pressure, very fast or irregular heartbeat, difficulty urinating, or severe skin reactions with blistering or peeling.

Warnings and precautions:

• Do not use in anyone younger than 12 years, right before or after heart bypass surgery, or if you have had a serious reaction to aspirin, other NSAIDs, or pseudoephedrine.
• Use only with medical advice if you are pregnant (especially at 20 weeks or later), breastfeeding, over 60, have high blood pressure, heart disease, prior heart attack or stroke, kidney or liver disease, asthma, thyroid disease, diabetes, stomach ulcers or bleeding, or prostate enlargement, or if you take blood thinners, diuretics, other NSAIDs, or other decongestants.

Relative safety: For short-term use in generally healthy adults, its safety is similar to other NSAID plus decongestant combinations, but naproxen can increase the risk of heart attack, stroke, and serious stomach bleeding, and pseudoephedrine can raise blood pressure and heart rate, so people with cardiovascular or gastrointestinal risk factors need extra caution.

Reporting side effects and safety updates: Side effects should be reported to a healthcare professional and to the FDA MedWatch program, and patients can check the current Drug Facts label or FDA website for the latest safety communications and warnings.

Major drug and supplement interactions:

• Other NSAIDs or products containing naproxen, ibuprofen, aspirin, or ketoprofen, which increase the risk of stomach bleeding, kidney problems, and other side effects.
• Blood thinners and antiplatelet drugs (such as warfarin, apixaban, rivaroxaban, or clopidogrel), SSRIs/SNRIs, and corticosteroids, which together with naproxen can raise bleeding risk.
• Blood pressure medicines and diuretics (ACE inhibitors, ARBs, beta-blockers, “water pills”), since naproxen and pseudoephedrine may reduce their effect and stress the kidneys.
• Lithium, methotrexate, and some other prescription drugs whose blood levels can be increased by NSAIDs.
• MAO inhibitors and other decongestants or stimulants (such as phenylephrine, ephedrine, or certain ADHD medicines), which can cause dangerously high blood pressure or heart rhythm problems.
• Herbal supplements that affect clotting or blood pressure (for example, ginkgo, garlic, ginseng, St. John’s wort), which may further increase bleeding or cardiovascular risks.

Food, alcohol, and lifestyle interactions:

• Alcohol increases the chance of stomach irritation and bleeding and should be limited or avoided while using this medicine.
• Caffeine and other stimulants may worsen nervousness, rapid heartbeat, or insomnia caused by pseudoephedrine.

Precautions and when use may be unsafe:

• Avoid use or obtain medical advice first if you have uncontrolled high blood pressure, serious heart disease, a history of heart attack or stroke, stomach ulcers or bleeding, severe kidney or liver disease, or difficulty urinating due to prostate problems.
• Always tell your doctors, dentists, and pharmacists that you are taking Aleve-D Sinus and Cold before starting or changing any prescription, over-the-counter, or herbal medicines.

Monitoring needs: People with high blood pressure, heart disease, kidney disease, or those on interacting medications may need monitoring of blood pressure, kidney function, and for signs of bleeding if they use this product, especially beyond a few days.

Q: What is Aleve-D Sinus and Cold used for?
A: It is used for short-term relief of sinus pressure, nasal and sinus congestion, headache, minor body aches and pains, and fever from colds or flu in people 12 years and older.

Q: How long does one dose last and how often can I take it?
A: Each caplet can relieve symptoms for up to 12 hours, and adults and children 12 and older may take 1 caplet every 12 hours, but no more than 2 caplets in 24 hours.

Q: Can I take Aleve-D Sinus and Cold with regular Aleve or other NSAID pain relievers?
A: No, you should not take it with regular Aleve, other naproxen products, or other NSAIDs like ibuprofen or aspirin unless a clinician specifically tells you to, because this increases the risk of serious side effects.

Q: Is it safe if I have high blood pressure or heart disease?
A: Because naproxen and pseudoephedrine can raise blood pressure and affect the heart and blood vessels, people with high blood pressure, heart disease, prior heart attack, stroke, or heart failure should talk with a healthcare professional before using it, and may be advised to avoid it.

Q: Can I use Aleve-D Sinus and Cold during pregnancy or while breastfeeding?
A: It should not be used during pregnancy, especially at 20 weeks or later, or while breastfeeding unless your healthcare professional decides the benefits outweigh the risks and advises you exactly how to use it.

Q: Will Aleve-D Sinus and Cold make me sleepy?
A: It is considered non-drowsy because it does not contain an antihistamine, but the pseudoephedrine can cause nervousness or trouble sleeping, so it is often best not to take it close to bedtime.

Storage: Store at room temperature 20–25°C (68–77°F) in a dry place, in the original packaging, away from heat and moisture, and keep out of reach of children.

Disposal: Dispose of unused or expired caplets through a medicine take-back program when possible; if none is available, mix caplets (do not crush) with an undesirable substance (such as used coffee grounds or kitty litter), place in a sealed container or bag, and throw in the household trash, and always remove or scratch out personal information on empty packages before discarding.