{"active_ingredient":["Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug"],"ask_doctor":["Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers 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"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin 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 ibuprofen or any other pain reliever/fever reducer right before or after heart surgery"],"dosage_and_administration":["Directions: do not lake more than directed the smallest effective dose should be used adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor, children under 12 years ask a doctor"],"dosage_and_administration_table":["<table width=\"100%\"> <col width=\"50.000%\" align=\"left\"/> <col width=\"50.000%\" align=\"left\"/> <tbody> <tr> <td align=\"center\" valign=\"top\" styleCode=\"Toprule Botrule Lrule Rrule\">adults and children 12 years and older </td> <td align=\"left\" valign=\"top\" styleCode=\"Toprule Botrule Rrule\"> <list listType=\"unordered\" styleCode=\"Square\"> <item>take 1 tablet every 4 to 6 hours while symptoms persist </item> <item>if pain or fever does not respond to 1 tablet, 2 tablets may be used </item> <item>do not exceed 6 tablets in 24 hours, unless directed by a doctor, </item> </list> </td> </tr> <tr> <td align=\"center\" valign=\"top\" styleCode=\"Botrule Lrule Rrule\">children under 12 years </td> <td align=\"left\" valign=\"top\" styleCode=\"Botrule Rrule\"> <list listType=\"unordered\" styleCode=\"Square\"> <item>ask a doctor </item> </list> </td> </tr> </tbody> </table>"],"effective_time":"20191230","id":"f4128377-a30a-4fc5-8e9f-e3e4eccb798e","inactive_ingredient":["Inactive Ingredients colloidal silicon dioxide, corn starch, iron oxide red, polyethylene glycol, polyvinyl alcohol, povidone k30, pregelatinized starch, sodium starch, glycolate, stearic acid, talc, titanium dioxide"],"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. (1-800-222-1222)"],"openfda":{},"other_safety_information":["Other Information: Store between 20°-25°C (68°-77°F) Avoid excessive heat above 40°C (104°F) do not use if foil inner seal is broken or missing"],"package_label_principal_display_panel":["Principal Display Panel - 200 mg Pouch Label Safetec of America, Inc. DO NOT USE IF POUCH IS TORN OR DAMAGED Manufactured for Safetec of America, Inc. Buffalo NY 14215 Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)* GLUTEN-FREE 2 Coated Tablets Principal Display Panel - 200 mg Pouch Label","Principal Display Panel – 50 Pouches Carton Label Safetec ® of America, Inc. *Compare to the active ingredient in Advil® NDC 61010-4411-1 Ibuprofen Ibuprofen Tablets USP, 200 mg PUSH TO OPEN Dispense through opening Pain Reliever/Fever Reducer (NSAID)* Relieves minor aches and pains Fever reducer Coated tablets GLUTEN-FREE TAMPER EVIDENT UNIT DOSE POUCHES DO NOT USE IF POUCH IS TORN OR DAMAGED 50 Pouches 2 Tablets per pouch Principal Display Panel – 50 Pouches Carton Label","Principal Display Panel – 100 Pouches Carton Label Safetec ® of America, Inc. *Compare to the active ingredient in Advil® NDC 61010-4411-2 Ibuprofen Ibuprofen Tablets USP, 200 mg - Pain Reliever/Fever Reducer (NSAID)* GLUTEN-FREE Relieves minor aches and pains Fever reducer Coated tablets PUSH TO OPEN Dispense through opening TAMPER EVIDENT UNIT DOSE POUCHES DO NOT USE IF POUCH IS TORN OR DAMAGED 100 Pouches 2 Tablets per pouch Principal Display Panel – 100 Pouches Carton Label"],"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"],"questions":["Questions or comments? Call toll free: 1-800-456-7077"],"set_id":"eda3745a-1009-4a89-8ec6-c7d26d7e7275","spl_product_data_elements":["Ibuprofen Ibuprofen Ibuprofen Ibuprofen Silicon Dioxide Ferric Oxide Red POLYETHYLENE GLYCOL 4000 Polyvinyl alcohol, Unspecified Povidone K30 STARCH, CORN Stearic acid Sodium Starch Glycolate Type A Potato Talc Titanium dioxide red ROUND G;2"],"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 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)"],"version":"2","warnings":["Warnings: Allergy alert: Ibuprofen 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 ibuprofen or any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers 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 Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin 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"],"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"]}