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ALEVE ® LIQUID GELS


SPL UNCLASSIFIED SECTION

Drug Facts


Active ingredient (in each capsule)

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

Allergy alert

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

SPL UNCLASSIFIED SECTION

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

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

  • 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

Do not use

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

Ask a doctor before use if

  • the 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, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding: feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get better
  • you have symptoms of heart problems or stroke: chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swelling

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 12 years and older:take 1 capsule every 8 to 12 hours while symptoms lastfor the first dose you may take 2 capsules within the first hourdo not exceed 2 capsules in any 8- to 12-hour perioddo not exceed 3 capsules in a 24-hour period
children under 12 years:ask a doctor
  • do not take more than directed
  • the smallest effective doses hould be used
  • drink a full glass of water with each dose
  • if taken with food, this product may take longer to work

Inactive ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol


Other information

  • each capsule contains: sodium 20 mg
  • store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F)
  • read all directions and warnings before use. Keep carton.

SPL UNCLASSIFIED SECTION

Distributed by:

Whippany

Bayer Healthcare LLC

Whippany, NJ 07981


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EZ OPEN ARHTRITIS CAP

ALL DAY STRONG®ALEVE ®LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)pain reliever/fever reducer

STRENGTH TO LAST 12 HOURS

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

80

CAPSULES

(LIQUID FILLED CAPSULES)