{"active_ingredient":["Drug Facts Active ingredient (in each capsule) Solubilized Ibuprofen equal to 200 mg Ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug"],"ask_doctor":["Ask a doctor before use if • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • 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"],"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 ibuprofen 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 adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor"],"effective_time":"20241003","id":"f4cf2176-7715-4a56-a0f0-ccda01ad91c9","inactive_ingredient":["Inactive ingredients ammonium hydroxide, caprylic and capric acid triglycerides, gelatin, isopropyl alcohol, lecithin, macrogol/PEG 400, polyethylene glycol, polyvinyl acetate phthalate, potassium hydroxide, propylene glycol, purified water, SDA 35A alcohol, sorbitol sorbitan solution, titanium dioxide."],"indications_and_usage":["Uses • temporarily relieves minor aches and pains due to: • headache • backache • the common cold • minor pain of arthritis • toothache • menstrual cramps • muscular aches • 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 capsule contains: potassium 20 mg • read all warnings and directions before use. Keep carton. • store at 20-25 o C (68-77 o F) • avoid excessive heat above 40 o C (104 o F) • You may report side effects to FDA at 1-800-FDA-1088"],"package_label_principal_display_panel":["Ibuprofen bottle label 200 mg (40 count, 80 count, 160 count - label unchanged except amount of product) NDC 70968-327-01 Ibuprofen Capsules 200 mg Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer ( NSAID ) Free from Artificial Dyes and Preservatives 40 Softgels** **Liquid Filled Capsules SOFGEN PHARMACEUTICALS READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION Uses • temporarily relieves minor aches and pains due to: headache, muscular aches, menstrual cramps, the common cold, backache, toothache, minor pain of arthritis. • temporarily reduces fever. Warnings • Ask your doctor before use if you are pregnant, under a doctor’s care for a serious condition, age 60 or over, taking any other drug or have stomach problems. • This product 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. Do not use this product if you have ever had an allergic reaction to any pain reliever/fever reducer. • Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 seal under bottle cap imprinted in red text with \" SEALED for YOUR PROTECTION \" is broken or missing. 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. Directions • do not take more than directed • the smallest effective dose should be used • adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist • if pain or fever does not respond to 1 capsule, 2 capsules may be used • do not exceed 6 capsules in 24 hours, unless directed by a doctor • children under 12 years: ask a doctor Each capsule contains : potassium 20 mg • You may report side effects to FDA at 1-800-FDA-1088 Manufactured by: USGP a division of PROCAPS S.A. Barranquilla, Colombia. Dist by: SOFGEN Pharmaceuticals, LLC. C17090102. Rev, 09/17 327 SfGel DF pg1 327 SfGel DF pg2","Ibuprofen retail label 200 mg (40 count, 80 count, 160 count - label unchanged except amount of product) NDC 70968-327-01 Ibuprofen Capsules 200 mg Solubilized Ibuprofen Capsules, 200 mg Pain reliever/Fever Reducer (NSAID) Free from Artificial Dyes and Preservatives 40 Softgels** ** Liquid Filled Capsules SOFGEN PHARMACEUTICALS READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION Drug Facts Active ingredient (in each capsule) Solubilized Ibuprofen equal to 200 mg Ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug Purpose Pain reliever/Fever reducer Uses • temporarily relieves minor aches and pains due to: • headache • backache • the common cold • minor pain of arthritis • toothache • menstrual cramps • muscular aches • temporarily reduces fever Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • asthma (wheezing) • skin reddening • blisters • facial swelling • shock • rash 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 • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • 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 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 ibuprofen 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 • 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 Ibuprofen 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) Directions • do not take more than directed • the smallest effective dose should be used • adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist • if pain or fever does not respond to 1 capsule, 2 capsules may be used • do not exceed 6 capsules in 24 hours, unless directed by a doctor • children under 12 years: ask a doctor Other information • each capsule contains : potassium 20 mg • read all warnings and directions before use. Keep carton. • store at 20-25 o C (68-77 o F) • avoid excessive heat above 40 o C (104 o F) Inactive ingredients ammonium hydroxide, caprylic and capric acid triglycerides, gelatin, isopropyl alcohol, lecithin, macrogol/PEG 400, polyethylene glycol, polyvinyl acetate phthalate, potassium hydroxide, propylene glycol, purified water, SDA 35A alcohol, sorbitol sorbitan solution, titanium dioxide. • You may report side effects to FDA at 1-800-FDA-1088 Do Not Use if seal under bottle cap imprinted in red text with \" SEALED for YOUR PROTECTION \" is broken or missing. Manufactured by: USGP a division of PROCAPS S.A. Barranquilla, Colombia. Dist by: SOFGEN Pharmaceuticals, LLC. Rev, 09/17 327 SfGel DF Outer"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use. It is especially important not to use ibuprofen 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"],"set_id":"be74cf52-db40-4e21-9703-c7c18e90af1b","spl_product_data_elements":["IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN AMMONIA MEDIUM-CHAIN TRIGLYCERIDES GELATIN ISOPROPYL ALCOHOL LECITHIN, SOYBEAN POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ACETATE PHTHALATE POTASSIUM HYDROXIDE PROPYLENE GLYCOL WATER ALCOHOL SORBITAN SORBITOL TITANIUM DIOXIDE light yellow to clear brown L2C"],"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 • redness or swelling is present in the painful area • any new symptoms appear"],"version":"14","warnings":["Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • asthma (wheezing) • skin reddening • blisters • facial swelling • shock • rash 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."],"when_using":["When using this product • take with food or milk if stomach upset occurs"]}