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spl product data elements
Naproxen Sodium NAPROXEN SODIUM CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 POLYETHYLENE GLYCOL, UNSPECIFIED MAGNESIUM STEARATE POLYVINYL ALCOHOL POVIDONE STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE NAPROXEN SODIUM NAPROXEN Biconvex I7
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredient (in each caplet) 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
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 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. (1-800-822-1222)
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
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 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.
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. (1-800-822-1222)
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 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
dosage and administration table
<table width="65%"><col width="30%" align="left" valign="top"/><col width="70%" align="left" valign="top"/><tbody><tr styleCode="Botrule First"><td align="left" styleCode="Rrule Toprule">Adults and children 12 years and older</td><td align="left" styleCode="Toprule"><list listType="unordered" styleCode="Square"><item>take 1 caplet every 8 to 12 hours while symptoms last</item><item>for the first dose you may take 2 caplets within the first hour</item><item>do not exceed 2 caplets in any 8- to 12-hour period</item><item>do not exceed 3 caplets in a 24-hour period</item></list></td></tr><tr><td align="left" styleCode="Rrule">Children under 12 years</td><td align="left"><list listType="unordered" styleCode="Square"><item>ask a doctor</item></list></td></tr></tbody></table>
储存 / Storage and handling
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).
辅料 / Inactive ingredients
Inactive ingredients croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide
package label principal display panel
PRINCIPAL DISPLAY PANEL QUALITY CHOICE® NDC 83324-108-50 †Compare to the Active Ingredient in Aleve® Naproxen Sodium Tablets, 220 mg Pain Reliever/Fever Reducer (NSAID) Strength to Last 12 Hours Actual Size 50 CAPLETS** **Capsule-Shaped Tablets image description
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20250520
- 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.

