{"active_ingredient":["Active ingredient(in each capsule) 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 if taken with food, this product may take longer to work Adults and children 12 years and older: take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules in a 24-hour period Children under 12 years ask a doctor"],"dosage_and_administration_table":["<table ID=\"id_d9660161-7d96-40b8-a55f-2d685e60bfc0\" border=\"single\" width=\"435\"> <col width=\"25.3%\"/> <col width=\"80.7%\"/> <tbody> <tr ID=\"id_e4cb099f-8eb6-4bf5-9482-9c68b5c67778\"> <td align=\"left\" styleCode=\"Botrule Toprule Rrule Lrule\" valign=\"top\"> <paragraph>Adults and children 12 years and older:</paragraph> </td> <td align=\"left\" styleCode=\"Botrule Rrule\" valign=\"top\"> <list listType=\"unordered\"> <item>take 1 capsule every 8 to 12 hours while symptoms last</item> <item>for the first dose you may take 2 capsules within the first hour</item> <item>do not exceed 2 capsules in any 8- to 12-hour period</item> <item>do not exceed 3 capsules in a 24-hour period</item> </list> </td> </tr> <tr ID=\"id_5e5a846b-4944-497e-a1a6-5fc2fc99a6ef\"> <td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\"> <paragraph>Children under 12 years</paragraph> </td> <td align=\"left\" styleCode=\"Botrule Rrule\" valign=\"top\"> <list listType=\"unordered\"> <item>ask a doctor</item> </list> </td> </tr> </tbody> </table>"],"effective_time":"20101213","id":"30036467-5525-479f-acb7-9476b82cf69f","inactive_ingredient":["Inactive ingredients FD&C Blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol Manufactured by: Banner Pharmacaps Inc. 4125 Premier Drive High Point, NC 27265"],"indications_and_usage":["Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps 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-Shipping Label NDC 10888-7121 Naproxen sodium, 220 mg (Liquid Filled Capsules) 6,000 Softgels IMPORTANT This bulk shipment, is intended for further processing only. It is not to be used in its present condition, and it should be re-packaged immediately, and labeled strictly in conformance with the FD&C Act and regulations. Store below 60% relative humidity at 59°-86°F (15°-30°C)-do not refrigerate. CAUTION: FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING ONLY BANNER PHARMACAPS INC. BULK LABEL 220 mg"],"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":["Purposes Pain reliever/fever reducer"],"set_id":"802ed9d5-e0b2-40e4-856d-a7674ddfd016","spl_product_data_elements":["NAPROXEN SODIUM NAPROXEN SODIUM NAPROXEN SODIUM NAPROXEN FD&C BLUE NO. 1 GELATIN GLYCERIN LACTIC ACID MANNITOL POLYETHYLENE GLYCOL POVIDONE PROPYLENE GLYCOL WATER SORBITAN SORBITOL"],"spl_unclassified_section":["Drug Facts","Other information each capsule contains: sodium 20 mg store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F). do not use if carton is open or if Tamper-Evident seal under bottle cap imprinted with “Sealed for Your Protection” is broken or missing. do not use if Tamper-Evident seal under bottle cap is broken or missing. read all directions and warnings before use. Keep carton."],"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 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 stomach pain or upset gets worse or lasts redness or swelling is present in the painful area any new symptoms appear you have difficulty swallowing it feels like the capsule is stuck in your throat"],"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"],"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"]}