Naproxen Sodium NAPROXEN SODIUM L.N.K. INTERNATIONAL, INC. FDA Approved Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache the common cold menstrual cramps backache temporarily reduces fever Uses temporarily relieves minor aches and pains due to: headache muscular aches the common cold toothache backache menstrual cramps minor pain of arthritis temporarily reduces fever

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug Active ingredient (in each caplet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients croscarmellose sodium FD&C blue #2 aluminum lake magnesium stearate microcrystalline cellulose polyethylene glycol polyvinyl alcohol povidone silicon dioxide talc titanium dioxide Inactive ingredients croscarmellose sodium FD&C blue #2 aluminum lake magnesium stearate microcrystalline cellulose polyethylene glycol polyvinyl alcohol povidone silicon dioxide talc titanium dioxide
Strengths
220 mg 200 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Muscular Aches Minor Pain Of Arthritis Toothache The Common Cold Menstrual Cramps Backache Temporarily Reduces Fever Uses Temporarily Relieves Minor Aches And Pains Due To Headache Muscular Aches The Common Cold Toothache Backache Menstrual Cramps Minor Pain Of Arthritis Temporarily Reduces Fever
Pill Appearance
Shape: round Color: blue Imprint: 44;604

Identifiers & Packaging

Container Type BOX
UPC
0050844604094 0050844417168
UNII
9TN87S3A3C
Packaging

Principal display panel QUALITY +PLUS NDC 50844-417-16 † Compare to active ingredient in Aleve® Tablets NAPROXEN SODIUM TABLETS, 220 mg PAIN RELIEVER/ FEVER REDUCER (NSAID) STRENGTH TO LAST 12 HOURS 1000 Coated Tablets ACTUAL SIZE TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING † This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Aleve® Tablets. 50844 REV1221C41716 Distributed by: LNK INTERNATIONAL, INC. 60 Arkay Drive, Hauppauge, NY 11788 USA Quality Plus 44-417 Quality Plus 44-417; Principal display panel QUALITY +PLUS NDC 50844-604-09 † Compare to the active ingredient in Menstridol ® NAPROXEN SODIUM TABLETS, 220 mg PAIN RELIEVER/FEVER REDUCER (NSAID) UP TO 12 HOURS OF MENSTRUAL PAIN RELIEF Temporarily relieves minor cramps, backache, headache 20 Coated Caplets** **CAPSULE-SHAPED TABLETS ACTUAL SIZE TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING † This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Menstridol®. 50844 REV1221C60409 Distributed by: LNK INTERNATIONAL, INC. 60 Arkay Drive Hauppauge, NY 11788 USA Quality Plus 44-604 Quality Plus 44-604

Package Descriptions
  • Principal display panel QUALITY +PLUS NDC 50844-417-16 † Compare to active ingredient in Aleve® Tablets NAPROXEN SODIUM TABLETS, 220 mg PAIN RELIEVER/ FEVER REDUCER (NSAID) STRENGTH TO LAST 12 HOURS 1000 Coated Tablets ACTUAL SIZE TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING † This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Aleve® Tablets. 50844 REV1221C41716 Distributed by: LNK INTERNATIONAL, INC. 60 Arkay Drive, Hauppauge, NY 11788 USA Quality Plus 44-417 Quality Plus 44-417
  • Principal display panel QUALITY +PLUS NDC 50844-604-09 † Compare to the active ingredient in Menstridol ® NAPROXEN SODIUM TABLETS, 220 mg PAIN RELIEVER/FEVER REDUCER (NSAID) UP TO 12 HOURS OF MENSTRUAL PAIN RELIEF Temporarily relieves minor cramps, backache, headache 20 Coated Caplets** **CAPSULE-SHAPED TABLETS ACTUAL SIZE TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING † This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Menstridol®. 50844 REV1221C60409 Distributed by: LNK INTERNATIONAL, INC. 60 Arkay Drive Hauppauge, NY 11788 USA Quality Plus 44-604 Quality Plus 44-604

Overview

Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache the common cold menstrual cramps backache temporarily reduces fever Uses temporarily relieves minor aches and pains due to: headache muscular aches the common cold toothache backache menstrual cramps minor pain of arthritis temporarily reduces fever

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache the common cold menstrual cramps backache temporarily reduces fever Uses temporarily relieves minor aches and pains due to: headache muscular aches the common cold toothache backache menstrual cramps minor pain of arthritis temporarily reduces fever

Dosage & 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 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

Warnings & Precautions
Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives shock rash blisters skin reddening facial swelling asthma (wheezing) 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 have had stomach ulcers or bleeding problems are age 60 or older take a blood thinning (anticoagulant) or steroid drug take more or for a longer time than directed 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 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 are taking a diuretic 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 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: leg swelling chest pain slurred speech trouble breathing weakness in one part or side of body pain gets worse or lasts more than 10 days you have difficulty swallowing any new symptoms appear fever gets worse or lasts more than 3 days it feels like the pill is stuck in your throat redness or swelling is present in the painful area 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. Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: asthma (wheezing) skin reddening shock blisters rash facial swelling hives 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] take more or for a longer time than directed have 3 or more alcoholic drinks every day while using this product 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 are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke 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: slurred speech trouble breathing leg swelling weakness in one part or side of body chest pain 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

Purpose Pain reliever/fever reducer Purpose 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 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 When using this product take with food or milk if stomach upset occurs

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 you have symptoms of heart problems or stroke: leg swelling chest pain slurred speech trouble breathing weakness in one part or side of body pain gets worse or lasts more than 10 days you have difficulty swallowing any new symptoms appear fever gets worse or lasts more than 3 days it feels like the pill is stuck in your throat redness or swelling is present in the painful area 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: slurred speech trouble breathing leg swelling weakness in one part or side of body chest pain 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Storage & Handling

Other information each tablet contains: sodium 20 mg use by expiration date on package store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F) Other information each caplet contains: sodium 20 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F) see end flap for expiration date and lot number

Questions

Questions or comments? Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday Questions or comments? Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday


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