{"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, 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":["<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"48%\"/><col width=\"49%\"/><tbody><tr><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph>Adults and children 12 years and older</paragraph></td><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>take 1 tablet every 8 to 12 hours while symptoms last</item><item><caption>&#x2022;</caption>for the first dose you may take 2 tablets within 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></td></tr><tr><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph>Children under 12 years</paragraph></td><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><list listType=\"unordered\"><item><caption>&#x2022;</caption>ask a doctor</item></list></td></tr></tbody></table>"],"effective_time":"20260122","id":"e09a1afc-15a5-46b0-87f2-e2861fa61279","inactive_ingredient":["Inactive ingredients FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide"],"indications_and_usage":["Uses • temporarily relieves minor aches and pains 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 (1-800-222-1222)."],"openfda":{},"other_safety_information":["Other information • each tablet contains: sodium 22 mg • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F)."],"package_label_principal_display_panel":["Package/Label Principal Display Panel CAREone ® Compare to the active ingredient in Aleve ® Back & Muscle Pain Tablets NAPROXEN SODIUM Tablets 220mg Pain Reliever/Fever Reducer (NSAID) For temporary relief of minor back and muscle aches and pains BACK & MUSCLE PAIN Strength to last Actual Size 12 hrs 90 TABLETS 33d-of-naproxen-sodium.jpg"],"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? 1-800-719-9260"],"set_id":"0c9222e0-81e7-4591-b071-14b0e9cbf01e","spl_product_data_elements":["CareOne Naproxen Sodium Naproxen Sodium NAPROXEN SODIUM NAPROXEN FD&C BLUE NO. 2 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED TALC TITANIUM DIOXIDE Light Blue L490"],"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"],"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. 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 are taking a diuretic • 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: • 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 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 (1-800-222-1222)."],"when_using":["When using this product • take with food or milk if stomach upset occurs"]}