{"active_ingredient":["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"],"ask_doctor":["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 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 have problems or serious side effects from taking pain relievers or fever reducers you are taking a diuretic"],"ask_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","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"],"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"],"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","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"],"effective_time":"20260225","id":"89d3ed35-e75c-41d8-aa99-57cc1fd866d2","inactive_ingredient":["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"],"indications_and_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 menstrual cramps backache minor pain of arthritis temporarily reduces fever"],"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."],"openfda":{"application_number":["ANDA204872"],"brand_name":["Naproxen Sodium"],"generic_name":["NAPROXEN SODIUM"],"is_original_packager":[true],"manufacturer_name":["L.N.K. International, Inc."],"package_ndc":["50844-417-43","50844-417-22","50844-417-11","50844-417-99","50844-417-98","50844-417-19","50844-417-56","50844-417-14","50844-417-16","50844-604-99","50844-604-98","50844-604-19","50844-604-09","50844-604-56","50844-604-15","50844-604-14","50844-604-16","50844-604-06"],"product_ndc":["50844-417","50844-604"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["849574"],"spl_id":["89d3ed35-e75c-41d8-aa99-57cc1fd866d2"],"spl_set_id":["717518e4-2537-4229-b765-c6acfe963d4b"],"substance_name":["NAPROXEN SODIUM"],"unii":["9TN87S3A3C"],"upc":["0050844604063","0050844417168"]},"package_label_principal_display_panel":["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 50844-604-06 † Compare to active ingredient in Aleve® Caplets NAPROXEN SODIUM TABLETS, 220 mg (NSAID) PAIN RELIEVER/FEVER REDUCER STRENGTH TO LAST 12 HOURS 200 Coated Caplets** **CAPSULE-SHAPED TABLETS ACTUAL SIZE TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive, Hauppauge, NY 11788 USA † This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Aleve® Caplets. 50844 ORG122160406 Quality Plus 44-604 Quality Plus 44-604"],"pregnancy_or_breast_feeding":["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.","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."],"purpose":["Purpose Pain reliever/fever reducer","Purpose Pain reliever/fever reducer"],"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"],"set_id":"717518e4-2537-4229-b765-c6acfe963d4b","spl_product_data_elements":["Naproxen Sodium Naproxen Sodium NAPROXEN SODIUM NAPROXEN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE 44;417 Naproxen Sodium Naproxen Sodium NAPROXEN SODIUM NAPROXEN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE 44;604"],"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: 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: 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 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"],"storage_and_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 store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F) use by expiration date on package"],"version":"15","warnings":["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] 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 have problems or serious side effects from taking pain relievers or fever reducers you are taking a diuretic 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 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."],"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"]}