Naproxen Sodium Tablets, USP Pain Reliever/ Fever Reducer (NSAID) 220 mg

Compared to the active ingredient of Aleve® †

Drug Facts

ACTIVE INGREDIENT

Naproxen sodium USP, 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

INDICATION AND USAGE

Uses

• temporarily relieves minor aches and pains due to:
• backache
• muscular aches
• minor pain of arthritis
• 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:

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: NSAID, 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

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 DOCTOR/PHARMACIST

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

• 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

WHEN USING

When using this product

• take with food or milk if stomach upset occurs

STOP USE

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

PREGNANCY OR BREAST FEEDING

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of 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

Other information

• each tablet contains: sodium 20 mg
• store at 20 to 25°C (68 to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).

INACTIVE INGREDIENT

croscarmellose sodium, FD&C Blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc and titanium dioxide

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ  08807

†This product is not manufactured or distributed by Bayer Healthcare, LLC., distributor of Aleve®

Rev. 05-2022-03