Bayer Aleve

Unifirst First Aid Corporation

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet)
• Purposes
• Bayer Aleve Uses
• Warnings
• Do not use
• Ask a doctor before use if
  • Ask a doctor or pharmacist before use if you are
• When using this product
  • Stop use and ask a doctor if
• Directions
• Bayer Aleve Other information
• Inactive ingredients
• Questions or comments?

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each caplet)

Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to
  • minor pain of arthritis
  • muscular aches
  • backache
  • menstrual cramps
  • headache
  • toothache
  • the common cold
• temporarily reduces fever

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 stomach ulcers or bleeding problems
• take a blood thinner (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

Do not use

• if you ever have had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

Ask a doctor before use if

• 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
• you are taking a diuretic
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have asthma

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

• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• you have difficulty swallowing
• it feels like the pill is stuck in your throat
• redness or swelling is present in the painful area
• any new symptoms appear

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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not take more than directed
• the smallest effective dose should be used
• drink a full glass of water with each dose

Adults and children:        Take 1 caplet every 8 to 12 hours while symptoms last.
(12 years and older)        For the first dose you may take 2 caplets within the first hour. Do not exceed 2 caplets in any 8 to 12 hour period or 3 caplets in a 24 hour period.

Children under 12 years:        Ask a doctor.

Other information

• each caplet contains: Sodium 20 mg
• store at room temperature 68-77ºF (20-25ºC)
• avoid high humidity and excessive heat above 104ºF (40ºC)

Inactive ingredients

FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

1-800-395-0689 (Mon-Fri 9AM-5PM EST) or www.aleve.com

488B Bayer Aleve Label

All Day Strong^®

Aleve_®

naproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducer

Bayer

Pull To Open

Strength To Last 12 Hours

50 Caplets

Capsule-Shaped Tablets