{"active_ingredient":["Active ingredient (in each tablet) 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 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_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if • under a doctor's care for any serious condition • 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 to12 hours while symptoms last • for first dose you may take 2 tablets with in 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":["<table cellpadding=\"0pt\" cellspacing=\"0pt\" width=\"100%\"><col width=\"33%\"/><col width=\"65%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Adults and children 12 years and older:    </paragraph></td><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>take 1 tablet every 8 to12 hours while symptoms last </item><item><caption>&#x2022;</caption>for first dose you may take 2 tablets with in the first hour </item><item><caption>&#x2022;</caption>do not exceed 2 tablets in any 8-to 12-hour period </item><item><caption>&#x2022;</caption>do not exceed 3 tablets in a 24-hour period</item></list><paragraph>  </paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Children under 12 years:  </paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>ask a doctor</item></list></td></tr></tbody></table>"],"effective_time":"20210803","id":"af2646d2-4545-4d15-9c36-e0c4f95c3f73","inactive_ingredient":["Inactive ingredients Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide."],"indications_and_usage":["Uses temporarily relieves minor aches and pain due to: • backache • muscular aches • minor pain of arthritis • menstrual cramps • headache • 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 right away."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel Naproxen Sodium Tab USP 220mg"],"pregnancy_or_breast_feeding":["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."],"purpose":["Purpose Pain reliever/ fever reducer"],"questions":["Questions or comments? Call 1-800-540-3765"],"set_id":"1c7e7c4d-729c-4b6d-a292-b11dbf2a0b18","spl_product_data_elements":["Naproxen Sodium Naproxen Sodium SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED TITANIUM DIOXIDE NAPROXEN SODIUM NAPROXEN 144"],"spl_unclassified_section":["Other information • each tablet contains: sodium 20 mg • If side effects occur, you may report side effects to FDA at 1-800-FDA-1088"],"stop_use":["Stop use and ask doctor if • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have a stomach pain that dose 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"],"storage_and_handling":["Storage • Store at 20-25 o C (68-77 o F). Avoid high humidity and excessive heat above 40 0 C (104 0 F)"],"version":"4","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."],"when_using":["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"]}