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ALEVE COLD & SINUS (Bayer Healthcare)

Pain reliever / fever reducer / nasal decongestant

Active ingredients:
(in each caplet)                                          Purposes

Naproxen sodium 220 mg
(naproxen 200 mg) ............ 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


Allergy alert:   Naproxen sodium may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Alcohol warning:   If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take naproxen sodium or other pain relievers/fever reducers. Naproxen sodium may cause stomach bleeding.

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • 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.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • had serious side effects from any pain reliever/fever reducer

Ask a doctor or pharmacist before use if you are

  • using any other product containing naproxen or pseudoephedrine
  • taking any other pain reliever/fever reducer or nasal decongestant
  • under a doctor's care for any continuing medical condition
  • taking other drugs on a regular basis

When using this product do not use more than directed.

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you get nervous, dizzy, or sleepless
  • you develop heartburn
  • nasal congestion lasts more than 7 days
  • symptoms continue or get worse
  • you have trouble swallowing or the caplet feels stuck in your throat
  • new or unexpected symptoms occur
  • stomach pain occurs with use of this product or if even mild symptoms persist
  • fever lasts for more than 3 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.


  • 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: ask a doctor

Other information:

  • each caplet contains: sodium 20 mg
  • store at 20 to 25° C (68-77°F)
  • store in a dry place

Inactive Ingredients:   colloidal silicon dioxide, FD&C blue #1 lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyethylene glycol, povidone, propylene glycol, talc, titanium dioxide

Questions or comments? 1-800-395-0689 or

How Supplied

Boxes of 10, 20, or 30 caplets (capsule-shaped tablets)

Distributed by: Bayer Corporation

Consumer Care Division

Morristown, NJ 07960 USAB-R LLC


NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.