Aleve NAPROXEN SODIUM LIL' DRUG STORE PRODUCTS, INC FDA Approved 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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Substance Naproxen Sodium
Route
ORAL
Applications
NDA020204
Product NDC
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) 1 1 nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients FD&C blue #2 lake hypromellose magnesium stearate microcrystalline cellulose polyethylene glycol povidone talc titanium dioxide
Strengths
220 mg 200 mg
Treats Conditions
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
Pill Appearance
Shape: oval Color: blue Imprint: Aleve

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
9TN87S3A3C
Packaging

Principal Display Panel WHILE FOLDED ON LINE, TEAR OPEN AT DOT OR USE SCISSORS DO NOT USE IF POUCH IS TORN OR OPEN ALL DAY STRONG® ALEVE naproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducer STRENGTH TO LAST 12 HOURS 1 CAPLET CAPSULE-SHAPED TABLETS PDP/Package

Package Descriptions
  • Principal Display Panel WHILE FOLDED ON LINE, TEAR OPEN AT DOT OR USE SCISSORS DO NOT USE IF POUCH IS TORN OR OPEN ALL DAY STRONG® ALEVE naproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducer STRENGTH TO LAST 12 HOURS 1 CAPLET CAPSULE-SHAPED TABLETS PDP/Package

Overview

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

Indications & Usage

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

Dosage & Administration

Directions Do not take more than directed. T he smallest effective dose should be used. D rink 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.

Warnings & Precautions
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 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 In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose

Purposes Pain reliever/fever reducer

Do Not Use

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery

When Using

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 & Ask a Doctor

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

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.

Storage & Handling

Other informatin 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).

Questions

Questions or comments? 1-800-395-0689 (Mon-Fri 9AM-5PM EST) Dist. by: Bayer Healthcare LLC Whippany, NJ 07981 MADE IN MEXICO


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