ALEVE LIQUID GELS

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each capsule)

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

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purposes

Pain Reliever/Fever Reducer

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

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.

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.

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

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

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, 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product

• take with food or milk if stomach upset occurs

OTC - STOP USE SECTION

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
• you have symptoms of heart problems or stroke:
• chest pain
• trouble breathing
• slurred speech
• weakness in one part or side of body
• leg swelling
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear
• you have difficulty swallowing
• it feels like the capsule is stuck in your throat

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 at 20 weeks or later in 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

• do not take more than directed
• the smallest effective dose should be used
• drink a full glass of water with each dose
• if taken with food, this product may take longer to work

OTHER SAFETY INFORMATION

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).
• protect from light
• read all directions and warnings before use.

INACTIVE INGREDIENT SECTION

Inactive ingredients ammonium hydroxide, FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, purified water, sorbitan-sorbitol solution, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? 1-800-395-0689 (Mon-Fri 9AM – 5PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL