FDA Label for Up And Up Naproxen Sodium

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 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, 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 more than 10 days
• •fever gets worse or lasts 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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• •do not take more than directed
• •the smallest effective dose should be used
• •drink a full glass of water with each dose
take 1 caplet every 8 to 12 hours while symptoms last
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
do not exceed 3 caplets in a 24-hour period ask a doctor

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Adults and children 12 years and older
Children under 12 years

Other Information

• •each caplet contains: sodium 21 mg
• •store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive Ingredients

FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions?

Call 1-888-547-7400

Principal Display Panel

Compare to active ingredient in Aleve® Caplets

naproxen sodium tablets, 220 mg

pain reliever / fever reducer (NSAID)

strength to last 12 hours

ACTUAL SIZE

100 CAPLETS

100 CAPLETS†

(†CAPSULE-SHAPED TABLETS)