{"active_ingredient":["Active Ingredient/Tablet Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug"],"dosage_and_administration":["Directions do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings) adults: 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 children under 12 years: ask a doctor"],"effective_time":"20231205","id":"0bc6e5bf-cb1a-cedf-e063-6294a90a73ad","inactive_ingredient":["Inactive ingredients carnauba wax*, cellulose, croscarmellose sodium*, DC yellow 10*, FDC blue 2*, FDC red 40*, FDC yellow 6*, hydroxypropyl methylcellulose, magnesium stearate, maltodextrin*, polyethylene glycol*, polysorbate 80*, red iron oxide, silicon dioxide, sodium starch glycolate*, starch*, talc*, titanium dioxide, triacetin* *Contains one or more of these ingredients."],"indications_and_usage":["Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ the common cold ■ muscular aches ■ backache ■ toothache ■ minor pain of arthritis ■ 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{},"package_label_principal_display_panel":["Ibutab, 250 Box"],"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":"2f516c51-a1b5-4585-8de3-6271ad161608","spl_product_data_elements":["Ibutab Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 MAGNESIUM STEARATE MALTODEXTRIN POLYETHYLENE GLYCOL 300 POLYSORBATE 80 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TALC TITANIUM DIOXIDE TRIACETIN IBUPROFEN IBUPROFEN chocolate brown IBU;200 IBU;200"],"version":"5","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 ■ rash ■ skin reddening ■ blisters If an allergic reaction occurs, stop use and seek medical help right away. 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 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 a history of stomach problems, such as heartburn ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma ■ 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 to prevent 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 ■ 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 ■ redness or swelling is present in the painful area ■ any new symptoms appear"]}