ALEVE Tablets, Caplets* or Gelcaps** naproxen sodium tablets, USP

Active Ingredient

naproxen sodium

(in each tablet, caplet*, gelcap**)

220 mg (naproxen 200 mg)

Purpose

Pain reliever/fever reducer

Uses: Temporarily relieves minor aches and pains due to:

· common cold · backache

· headache · menstrual cramps

· toothache · minor pain of arthritis

· muscular aches

Temporarily reduces 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
with any other pain reliever/fever reducer
for more than 10 days for pain
for more than 3 days for fever

Ask a doctor before use if:

the painful area is red or swollen
you take other drugs on a regular basis
you are under a doctor' care for any continuing condition
you have had serious side effects from any pain reliever

Stop use and ask a doctor if:

an allergic reaction occurs, seek medical help right away
any new or unexpected symptoms occur
symptoms continue or worsen
you have difficulty swallowing
it feels like the pill is stuck in your throat
you develop heartburn
stomach pain occurs with use of this product or if even mild symptoms persist

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 SPECIFICALLY 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, seek professional assistance or contact a Poison Control Center immediately.

Dietary information (in each tablet, caplet*, gelcap**)

sodium 20 mg

Directions: Drink a full glass of water with each dose.

Adults: · Take 1 tablet (caplet*, gelcap**) every 8 to 12 hours while symptoms persist. For the first dose you may take
2 tablets (caplets*, gelcaps**) within the first hour. The smallest effective dose should be used.

Do not take more than:

2 tablets (caplets*, gelcaps**) in any 8 to 12 hour period
3 tablets (caplets*, gelcaps**) in a 24 hour period.

Over age 65: · Do not take more than 1 tablet (caplet*, gelcap**) every 12 hours unless directed by a doctor.

Children under 12 years of age: · Do not give this product to children under 12 unless directed by a doctor.

Inactive Ingredients (Tablets/Caplets*): magnesium stearate, microcrystalline cellulose, opadry YS-1-4215,
povidone, talc.

Inactive Ingredients (Gelcaps**): D&C; yellow #10 lake, edetate disodium, edible ink, FD&C; blue #1, FD&C;
yellow #6 lake, gelatin, glycerin, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, povidone, stearic acid, talc, titanium dioxide, and triacetin.

*capsule-shaped tablet(s)

**gelatin coated capsule-shaped tablet(s)

Store at room temperature: Avoid high humidity and excessive heat 104°F (40°C).

How Supplied: Aleve tablets in boxes of 24, 50, 100, 150. Caplets of 8, 24, 50, 100, 150, 200. Gelcaps of 20, 40, 80.

PRODUCT PHOTO(S):

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 and reproduced in full color by PDR as a quick-reference identification aid. 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' identity should be verified by chemical analysis.