Drugplain

Aleve-D Sinus and Cold 220 mg/1

naproxen sodium, pseudeoephedrine hydrochloride · TABLET · Bayer HealthCare LLC.

No Recall History
Plain English

Aleve-D Sinus and Cold is a tablet containing naproxen sodium, pseudeoephedrine hydrochloride at 220 mg/1, taken oral. Manufactured by Bayer HealthCare LLC..

Key Facts

Brand Name
Aleve-D Sinus and Cold
Generic Name
naproxen sodium, pseudeoephedrine hydrochloride
NDC Code (Product)
0280-6090
Manufacturer
Bayer HealthCare LLC.
Strength
220 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA076518
Marketing Start
01/01/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

abdominal pain upper1 reports
back pain1 reports
breast enlargement1 reports
diarrhoea1 reports
dizziness1 reports
eye pain1 reports
eye swelling1 reports
flushing1 reports
gastrooesophageal reflux disease1 reports
malaise1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

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.

Frequently Asked Questions

What is Aleve-D Sinus and Cold used for?

Aleve-D Sinus and Cold contains naproxen sodium, pseudeoephedrine hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.

Is Aleve-D Sinus and Cold a controlled substance?

Aleve-D Sinus and Cold is not classified as a controlled substance by the DEA.

What is the generic name for Aleve-D Sinus and Cold?

The generic name for Aleve-D Sinus and Cold is naproxen sodium, pseudeoephedrine hydrochloride. There are no other listed brand versions of naproxen sodium, pseudeoephedrine hydrochloride.

What is the NDC code for Aleve-D Sinus and Cold 220 mg/1?

The NDC (National Drug Code) for Aleve-D Sinus and Cold 220 mg/1 is 0280-6090, listed by Bayer HealthCare LLC..

Product NDC

0280-6090

Package NDC

0280-6090-10

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)