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spl product data elements
PROXEN NP 660 Naproxen Sodium HYPROMELLOSE, UNSPECIFIED FD&C BLUE NO. 2 ALUMINUM LAKE POVIDONE, UNSPECIFIED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE SILICON DIOXIDE CROSCARMELLOSE SODIUM NAPROXEN SODIUM NAPROXEN Light Blue Capsule-Shaped 220
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredient (in each tablet) Purposes Naproxen sodium 220 mg (naproxen 200mg) (NSAID)* .........Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug
用途 / Purpose
Active ingredient (in each tablet) Purposes Naproxen sodium 220 mg (naproxen 200mg) (NSAID)* .........Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug
适应证 / Indications and usage
Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ backache ■ muscular aches ■ the common cold ■ toothache ■ menstrual cramps ■ minor pain of arthritis ■ 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 ■ asthma (wheezing) ■ skin reddening ■ facial swelling ■ shock ■ 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 ■ side effects occur. You may report side effects to FDA at 1-800-FDA-1088. ■ 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.
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, 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
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 any other drug
使用中 / When using
停用事项 / Stop use
Stop use and ask a doctor if ■ side effects occur. You may report side effects to FDA at 1-800-FDA-1088. ■ 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
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 to12 hour period ■ do not exceed 3 tablets in a 24 hour period Children under 12 years ■ ask a doctor
储存 / Storage and handling
Other information ■ each tablet contains: sodium 20 mg ■ store at 20-25° C (68-77° F). Avoid high humidity and excessive heat above 40° C (104° F) ■ read all product information before using ■ TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
辅料 / Inactive ingredients
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide
questions
Questions or comments? Call: (619) 600-5632 (Mon-Fri 9AM – 5PM EST) or https://www.opmx.us
package label principal display panel
PRINCIPAL DISPLAY PANEL 12 CAPLETS NDC 69729-123-12 PROXEN NP 660 NAPROXEN SODIUM Arthritis/Artritis Backache/Dolor de Espalda Muscle and Joint Pain/ Dolor Muscular y de Articulaciones 12 Caplets Proxen
PRINCIPAL DISPLAY PANEL 24 CAPLETS NDC 69729-123-24 PROXEN NP 660 NAPROXEN SODIUM Arthritis/Artritis Backache/Dolor de Espalda Muscle and Joint Pain/ Dolor Muscular y de Articulaciones 24 Caplets Proxen 660 24
PRINCIPAL DISPLAY PANEL 100 CAPLETS NDC 69729-123-50 PROXEN NP 660 NAPROXEN SODIUM Arthritis/Artritis Backache/Dolor de Espalda Muscle and Joint Pain/ Dolor Muscular y de Articulaciones 100 Caplets P100
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20231227
- 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.

