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西药 · 美国药品标签原文

萘普生 · Aleve Gelcaps

NAPROXEN SODIUM

Aleve Gelcaps · Bayer HealthCare LLC.。此记录对应特定产品,标签收录不代表所有用途获批。

说明与适用边界

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spl product data elements

Aleve Gelcaps NAPROXEN SODIUM D&C YELLOW NO. 10 ALUMINUM OXIDE EDETATE DISODIUM FD&C BLUE NO. 1 FD&C YELLOW NO. 6 GELATIN GLYCERIN HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STEARIC ACID TALC TITANIUM DIOXIDE NAPROXEN SODIUM NAPROXEN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE ALEVE

spl unclassified section

Drug Facts Dist. by: Bayer HealthCare LLC Whippany, NJ 07981

活性成分 / Active ingredient

Active ingredient (in each tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) nonsteroidal anti-inflammatory drug

用途 / Purpose

Purposes Pain reliever/ fever reducer

适应证 / Indications and 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

警告 / 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 Heart Attack and Stroke Warning NSAIDs, 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 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, 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 Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs 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 you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling 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.

禁用事项 / 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

咨询医生 / Ask a doctor

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, 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

咨询医药人员 / Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin taking any other drug

使用中 / When using

When using this product take with food or milk if stomach upset occurs

停用事项 / 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 you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling 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

孕哺期 / Pregnancy or breastfeeding

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.

儿童安全 / 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.

用法用量原文 / Dosage and administration

Directions 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

dosage and administration table

<table border="0" width="100%"><tbody><tr><td><list listType="unordered"><item>Adults and children 12 years and older</item></list></td><td><list listType="unordered"><item>take 1 tablet every 8 to 12 hours while symptoms last</item><item>for the first dose you may take 2 tablets within the first hour</item><item>do not exceed 2 tablets in any 8- to 12-hour period</item><item>do not exceed 3 tablets in a 24-hour period</item></list></td></tr><tr><td><list listType="unordered"><item>Children under 12 years</item></list></td><td><list listType="unordered"><item>ask a doctor</item></list></td></tr></tbody></table>

储存 / Storage and handling

Other information each tablet contains: sodium 20 mg Store at 20-25ºC (68-77ºF). Avoid high humidity and excessive heat above 40°C (104°F).

辅料 / Inactive ingredients

Inactive ingredients D&C yellow #10 aluminum lake, edetate disodium, edible ink, FD&C blue #1, FD&C yellow #6 aluminum lake, gelatin, glycerin, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide

questions

Questions or comments? 1-800-395-0689 (Mon-Fri 9AM – 5PM EST)

package label principal display panel

EASY OPEN ARTHRITIS CAP ALL DAY STRONG® ALEVE® naproxen sodium tablets, 220 mg (NSAID) Pain reliever/fever reducer PACKAGE NOT CHILD-RESISTANT STRENGTH TO LAST 12 HOURS 160 GELCAPS GELATIN COATED CAPSULE-SHAPED TABLETS Front label back label

来源、版本与许可

资料类型
美国药品标签原文
版本
16 / 20251204
获取时间
2026-10-08
许可
openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.
核对原始来源