{"active_ingredient":["Active ingredient (in each caplet) Ibuprofen, USP 200 mg (NSAID 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, or asthma 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 do not take longer than 10 days, unless directed by a doctor (see Warnings ) adults and children 12 years and over take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years ask a doctor"],"dosage_and_administration_table":["
adults and children 12 years and overtake 1 caplet every 4 to 6 hours while symptoms persistif pain or fever does not respond to 1 caplet, 2 caplets may be useddo not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 yearsask a doctor
"],"effective_time":"20241206","id":"289b7de2-bf15-48ea-e063-6394a90a2f9d","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone K30, pregelatinized starch, sodium carboxymellose, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin"],"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."],"openfda":{"application_number":["ANDA079129"],"brand_name":["Ibuprofen"],"generic_name":["IBUPROFEN"],"is_original_packager":[true],"manufacturer_name":["AAA Pharmaceutical, Inc."],"nui":["N0000000160","M0001335","N0000175722"],"package_ndc":["57344-110-01","57344-110-02"],"pharm_class_cs":["Anti-Inflammatory Agents, Non-Steroidal [CS]"],"pharm_class_epc":["Nonsteroidal Anti-inflammatory Drug [EPC]"],"pharm_class_moa":["Cyclooxygenase Inhibitors [MoA]"],"product_ndc":["57344-110"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310965"],"spl_id":["289b7de2-bf15-48ea-e063-6394a90a2f9d"],"spl_set_id":["39e55ec1-213f-4996-adca-68a5ffbc409b"],"substance_name":["IBUPROFEN"],"unii":["WK2XYI10QM"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton RESTORE u NDC 57344-110-03 †COMPARE TO THE ACTIVE INGREDIENT IN ADVIL ® Ibuprofen Tablets, USP 200 mg Pain Reliever, Fever Reducer (NSAID) 100 COATED CAPLETS** (**capsule-shaped tablets) Principal Display Panel - 100 Tablet Bottle Carton"],"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":"39e55ec1-213f-4996-adca-68a5ffbc409b","spl_product_data_elements":["Ibuprofen Ibuprofen SILICON DIOXIDE STARCH, CORN DEXTROSE MONOHYDRATE HYPROMELLOSE, UNSPECIFIED FERRIC OXIDE RED LACTOSE MONOHYDRATE EGG PHOSPHOLIPIDS MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POVIDONE, UNSPECIFIED CARBOXYMETHYLCELLULOSE SODIUM SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN IBUPROFEN IBUPROFEN IBU;200"],"spl_unclassified_section":["Drug Facts","Distributed by: AAA Pharmaceutical, Inc. 681 Main Street Lumberton, NJ 08048"],"stop_use":["Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1-800-FDA-1088. 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"],"storage_and_handling":["Other information store between 20°-25°C (68°-77°F) avoid excessive heat above 40°C (104°F) read all warnings and directions before use retain carton for complete product information"],"version":"6","warnings":["Warnings Allergy alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives shock facial swelling skin reddening asthma (wheezing) 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 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, 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 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 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 side effects occur. You may report side effects to FDA at 1-800-FDA-1088. 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."],"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"]}