Aleve

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Aleve Recall

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Questions & Answers

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Side Effects & Adverse Reactions

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to

aspirin. Symptoms may include:

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

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

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID),

which may cause 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 an NSAID (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 you have

■ problems or serious side effects from taking pain relievers or fever reducers

■ stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain

■ ulcers ■ asthma

■ bleeding problems ■ high blood pressure

■ heart or kidney disease ■ taken a diuretic

■ reached age 60 or older

Ask a doctor or pharmacist before use if you are

■ taking any other drug containing an NSAID (prescription or nonprescription)

■ taking a blood thinning (anticoagulant) or steroid drug

■ 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 feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.

■ pain gets worse or lasts for more than 10 days

■ fever gets worse or lasts for more than 3 days

■ you have difficulty swallowing

■ it feels like the pill is stuck in your throat

■ you develop heartburn

■ stomach pain or upset gets worse or lasts

■ 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.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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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

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Aleve Manufacturers

Cardinal Health

Aleve | Cardinal Health

Directions

■ do not take more than directed

■ the smallest effective dose should be used

■ do not take longer than 10 days, unless directed by a doctor (see Warnings)

■ drink a full glass of water with each dose

Adults and children 12 years ■ take 1 caplet every 8 to 12 hours while symptoms last

and older ■ 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

Children under 12 years ■ ask a doctor

Other information

■ each caplet contains: sodium 20 mg

■ store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

No Recall
Bayer Healthcare Llc, Consumer Care

Aleve | Bayer Healthcare Llc, Consumer Care

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 adults and children 12 years and older: take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules in a 24-hour period children under 12 years: ask a doctor

No Recall
Bayer Healthcare Llc, Consumer Care

Aleve | Bayer Healthcare Llc, Consumer Care

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 adults and children 12 years and older: take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules in a 24-hour period children under 12 years: ask a doctor

No Recall
Bayer Healthcare Consumer Care

Aleve | Bayer Healthcare Consumer Care

do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose Adults and children 12 years and older take 1 tablet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8- to 12-hour period do not exceed 3 tablets in a 24-hour period Children under 12 years ask a doctor

No Recall
Lil’ Drug Store Products, Inc

Aleve | Lil' Drug Store Products, Inc

do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose Adults and children 12 years and older 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 Children under 12 years ask a doctor

No Recall