{"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 you are • 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 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":["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 periodask a doctor
Adults and children 12 years and older
• • • •
Children under 12 years
•
"],"effective_time":"20191115","id":"f9ef38ca-9e19-4e57-953d-210bf3c63ab8","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: • minor pain of arthritis • muscular aches • backache • 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":{},"package_label_principal_display_panel":["Principal Display Panel COMPARE to the active ingredient in ALEVE® 68788-8989-2 Bottles of 20 68788-8989-3 Bottles of 30 68788-8989-4 Bottles of 40 68788-8989- 6 Bottles of 60 All Day Relief Naproxen Sodium Tablets, USP 220 mg Pain Reliever/Fever Reducer (NSAID) Strength to Last 12 Hours Repackaged By: Preferred Pharmaceuticals Inc. Naproxen Sodium Tablets, 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? 1-800-645-2158"],"set_id":"aa5cbacc-1be5-43dc-bcdc-81d85d5bf1ec","spl_product_data_elements":["rugby all day relief Naproxen Sodium NAPROXEN SODIUM NAPROXEN 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 • 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 21 mg • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F)."],"version":"3","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 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, 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 a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking any other drug 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 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 • 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 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. 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 • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed"]}