{"active_ingredient":["Active ingredient (in each tablet) Naproxen sodium USP 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 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_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"],"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"],"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":["
Adults and children 12 years and older take 1 tablet every 8 to 12 hours while symptoms lastfor the first dose you may take 2 tablets within the first hourdo 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
"],"effective_time":"20250526","id":"277b3d51-eb63-4d99-91e0-aa44d0cc8053","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide"],"indications_and_usage":["Uses temporarily relieves minor aches and pains due to: headache minor pain of arthritis muscular aches backache menstrual cramps toothache the common cold 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 (1-800-222-1222) right away."],"openfda":{"application_number":["ANDA205497"],"brand_name":["Naproxen Sodium HEADACHE PAIN"],"generic_name":["NAPROXEN SODIUM"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"package_ndc":["58602-737-07","58602-737-12","58602-737-78","58602-737-21","58602-737-25","58602-737-29","58602-737-34","58602-737-38","58602-737-40","58602-737-44","58602-737-19"],"product_ndc":["58602-737"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["849574"],"spl_id":["277b3d51-eb63-4d99-91e0-aa44d0cc8053"],"spl_set_id":["10464576-0f9a-4a64-a388-3afe33682938"],"substance_name":["NAPROXEN SODIUM"],"unii":["9TN87S3A3C"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (24 Tablets, Container Label) AUROHEALTH NDC 58602-737-07 Naproxen Sodium Tablets, USP 220 mg (NSAID) HEADACHE PAIN Pain reliever Fever reducer For temporary relief of headache pain STRENGTH TO LAST 12 HOURS 24 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (24 Tablets, Container Label)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (24 Tablets Carton Label) AUROHEALTH NDC 58602-737-07 **Compare to Aleve ® Headache Pain active ingredient Naproxen Sodium Tablets, USP 220 mg (NSAID) HEADACHE PAIN Pain reliever fever reducer For temporary relief of headache pain STRENGTH TO LAST 12 HOURS 24 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (24 Tablets Carton Label)"],"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."],"purpose":["Purposes Pain reliever/fever reducer"],"questions":["Questions or comments? 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009"],"set_id":"10464576-0f9a-4a64-a388-3afe33682938","spl_product_data_elements":["Naproxen Sodium HEADACHE PAIN Naproxen Sodium NAPROXEN SODIUM NAPROXEN SILICON DIOXIDE FD&C BLUE NO. 2--ALUMINUM LAKE HYPROMELLOSE 2910 (5 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 200 POLYETHYLENE GLYCOL 8000 POVIDONE K30 TALC TITANIUM DIOXIDE light blue Circular J;67"],"spl_unclassified_section":["Naproxen Sodium Tablets, USP 220 mg Drug Facts"],"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"],"storage_and_handling":["Other information each tablet contains: sodium 20 mg store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F)."],"version":"5","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."],"when_using":["When using this product take with food or milk if stomach upset occurs"]}