| Pronunciation: | nah PROCK sen and sue doe eh FEH dren |
| Brand: | Aleve Cold and Sinus |
What is the most important information I should know about naproxen and pseudoephedrine?
| Do not crush or chew naproxen and pseudoephedrine. Swallow the tablets whole.
They are specially formulated to release slowly in your body. |
| If you drink more than three alcoholic beverages a day, ask your doctor whether you
should take naproxen and pseudoephedrine. This medication may cause stomach bleeding, and
alcohol may increase the occurrence of stomach bleeding. |
Do not take this medication for more than 3 days for fever or 10 days for pain.
What is naproxen and pseudoephedrine?
Naproxen is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs).
Naproxen is used to reduce pain and inflammation. Naproxen works by reducing hormones that
cause inflammation and pain in the body.
Pseudoephedrine is a decongestant. Pseudoephedrine is used to treat congestion
associated with allergies, hay fever, sinus irritation, and the common cold. It works by
constricting (shrinking) blood vessels (veins and arteries) in your body. The constriction of blood
vessels in your sinuses, nose, and chest allows drainage of those areas, which decreases
congestion.
Together, naproxen and pseudoephedrine are used to relieve symptoms of cold and flu.
Naproxen and pseudoephedrine may also be used for purposes other than those listed in
this medication guide.
Who should not take naproxen and pseudoephedrine?
Do not take naproxen and pseudoephedrine if you have taken a monoamine oxidase
inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine
(Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious
side effects.
| Do not take naproxen and pseudoephedrine without first talking to your doctor if you
have had an allergic reaction to aspirin, any other NSAID, or other pain reliever. |
Before taking naproxen and pseudoephedrine, tell your doctor if you
- drink more than three alcoholic beverages a day,
- have thyroid problems,
- have diabetes,
- have an enlarged prostate or difficulty urinating, or
- have heart disease, or
- have high blood pressure.
You may not be able to take naproxen and pseudoephedrine, or you
may require a dosage adjustment or special monitoring during treatment if you have any of the
conditions listed above.
| Do not take naproxen and pseudoephedrine without first talking to your doctor if you
are pregnant. It is especially important not to use naproxen during the last three months of
pregnancy unless specifically directed to do so by a doctor because it may cause problems in the
unborn child or complications during delivery. |
| Naproxen and pseudoephedrine passes into breast milk and may affect a nursing
infant. Do not take this medicine without first talking to your doctor if you are breastfeeding a
baby. |
| Do not use naproxen and pseudoephedrine to treat a child younger than 12 years of
age unless otherwise directed by a doctor. |
How should I take naproxen and pseudoephedrine?
Take naproxen and pseudoephedrine exactly as directed by your doctor. If you do not
understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
| Take each dose with a full glass of water. |
Naproxen and pseudoephedrine is usually taken twice a day, with doses 12 hours apart.
Do not take more than 2 tablets in a 24 hour period.
| Do not crush or chew naproxen and pseudoephedrine. Swallow the tablets whole.
They are specially formulated to release slowly in your body. |
Do not take naproxen and pseudoephedrine for more than 3 days for fever or 10 days for
pain.
Stop taking naproxen and pseudoephedrine and contact your doctor if nasal congestion
lasts longer than 7 days, if a fever lasts longer than 3 days, if your condition does not improve, if
your symptoms continue to get worse, or if your symptoms are accompanied by a high fever.
| Store naproxen and pseudoephedrine at room temperature away from moisture and
heat. |
What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for your
next dose, skip the missed dose and take only your next regularly scheduled dose. Do
not take a double dose of this medication.
What happens if I overdose?
| Seek emergency medical attention. |
Symptoms of a naproxen and pseudoephedrine overdose may include nausea, vomiting,
stomach pain, dizziness, drowsiness, headache, ringing in the ears, blurred vision, seizures,
sweating, numbness or tingling, little or no urine production, slow breathing, a slow heartbeat,
and coma.
What should I avoid while taking naproxen and pseudoephedrine?
| If you drink more than three alcoholic beverages a day, ask your doctor whether you
should take naproxen and pseudoephedrine. This medication may cause stomach bleeding, and
alcohol may increase the occurrence of stomach bleeding. |
Do not take any other product containing naproxen or pseudoephedrine or another
pain-reliever, fever reducer, or nasal decongestant during treatment with naproxen and
pseudoephedrine, unless otherwise directed by your doctor.
What are the possible side effects of naproxen and pseudoephedrine?
| If you experience an allergic reaction (difficulty breathing; closing of your throat;
swelling of your lips, tongue, or face; or hives) to naproxen and pseudoephedrine, stop taking the
medication and seek medical treatment immediately. |
If you experience any of the following side effects, stop taking naproxen and
pseudoephedrine and contact your doctor:
- nervousness, dizziness, or sleeplessness;
- heartburn or stomach pain;
- trouble swallowing or the tablet feels stuck in you throat;
- nasal congestion lasting more than 7 days;
- the occurrence of new or unexpected symptoms or
symptoms that continue to get worse; or
- fever lasting more than 3 days.
Side effects other than those listed here may also occur. Talk to your
doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect naproxen and pseudoephedrine?
Do not take naproxen and pseudoephedrine if you have taken a monoamine oxidase
inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine
(Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious
side effects.
Do not take any other product containing naproxen or pseudoephedrine or another
pain-reliever, fever reducer, or nasal decongestant during treatment with naproxen and
pseudoephedrine, unless otherwise directed by your doctor.
Other prescription and over-the-counter drugs may interact with naproxen and
pseudoephedrine and cause dangerous side effects. Do not take naproxen and pseudoephedrine
without first talking to your doctor if you are under a doctor's care for any continuing medical
condition if you take other prescription or over-the-counter medicines.
Drugs other than those listed here may also interact with naproxen and pseudoephedrine.
Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
Where can I get more information?
Your pharmacist has additional information about naproxen and pseudoephedrine written
for health professionals that you may read.
What does my medication look like?
Naproxen and pseudoephedrine is available over the counter under the brand name Aleve
Cold and Sinus. Other brand or generic formulations may also be available. Ask your pharmacist
any questions you have about this medication, especially if it is new to you.
- Aleve Cold and Sinus 220 mg naproxen sodium/120 mg
pseudoephedrine--yellow extended-release, capsule-shaped tablets
Remember, keep this and all other medicines out of the reach of children, never share
your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.
Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2003 Cerner Multum, Inc. Version: 1.04. Revision date: 2/13/04.