{"active_ingredient":["Active ing redient (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 have a history of stomach problems, such as heartburn _ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease _ you have asthma _ 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 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 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":"20170201","id":"d8959e17-0c78-4619-90ae-9510e6c9d0e2","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"],"indications_and_usage":["Uses _ temporarily relieves minor aches and pains due to: _ toothache _ muscular aches _ the common cold _ headache _ menstrual cramps _ backache _ minor pain of arthritis _ temporarily reduces fever Drug Facts (continued)"],"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. Drug Facts (continued)"],"openfda":{},"other_safety_information":["Other information _ each caplet contains: sodium 20 mg _ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN _ 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 Drug Facts (continued)"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL b+b better by giving PRINCIPAL DISPLAY PANEL b+b better by giving"],"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 *nonsteroidal anti-inflammatory drug"],"questions":["Questions or comments? 1-800-901-2420 Dist. by Breeden Brothers, LLC Nashville, TN 37219"],"set_id":"04c73d7b-ca24-45da-a395-d3b30f6c7b1e","spl_product_data_elements":["Naproxen Sodium Caplets Naproxen sodium NAPROXEN SODIUM NAPROXEN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE SILICON DIOXIDE TALC TITANIUM DIOXIDE 44;604"],"spl_unclassified_section":["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 _ 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":"1","warnings":["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 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 a blood thinning (anticoagulant) or steroid drug _ take more or for a longer time than directed Drug Facts (continued) 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 have asthma _ 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 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 Drug Facts (continued) 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 (1-800-222-1222) right away. Drug Facts (continued)"],"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 Drug Facts (continued)"]}