{"active_ingredient":["ACTIVE INGREDIENT(S) 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 ■ 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 take more than directed • the smallest effective dose should be used adults and children 12 years and older take 1 caplet/tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet/tablet, 2 caplets/tablets may be used do not exceed 6 caplets/tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor"],"dosage_and_administration_table":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\" width=\"947\"><col width=\"30.0908322771441%\"/><col width=\"69.9091677228559%\"/><tbody><tr styleCode=\"Botrule\"><td align=\"justify\" styleCode=\"Lrule Rrule\" valign=\"top\"><content styleCode=\"bold\"> adults and children 12 years and older</content> </td><td styleCode=\"Rrule\" valign=\"top\"><list listType=\"unordered\"><item>take 1 caplet/tablet every 4 to 6 hours while symptoms persist</item><item>if pain or fever does not respond to 1 caplet/tablet, 2 caplets/tablets may be used</item><item>do not exceed 6 caplets/tablets in 24 hours, unless directed by a doctor <content styleCode=\"bold\"/></item></list></td></tr><tr><td align=\"justify\" styleCode=\"Lrule Rrule\" valign=\"top\"><content styleCode=\"bold\"> children under 12 years</content> </td><td styleCode=\"Rrule\" valign=\"top\"><list listType=\"unordered\"><item>ask a doctor <content styleCode=\"bold\"/></item></list></td></tr></tbody></table>"],"effective_time":"20260615","id":"5447b3da-b7bc-776b-e063-6394a90a1027","inactive_ingredient":["Inactive Ingredients colloidal silicon dioxide, FD&C Yellow #6, maize starch, Povidone k30, polyethylene glycol, polyvinyl alcohol, 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":{"application_number":["ANDA202312"],"brand_name":["IBUPROFEN"],"generic_name":["IBUPROFEN"],"is_original_packager":[true],"manufacturer_name":["Granules India Limited"],"nui":["N0000000160","M0001335","N0000175722"],"package_ndc":["62207-321-41","62207-321-42","62207-321-43","62207-321-46","62207-321-47","62207-321-48","62207-321-49","62207-321-91","62207-321-89","62207-321-90","62207-320-41","62207-320-42","62207-320-43","62207-320-46","62207-320-47","62207-320-48","62207-320-49","62207-320-91","62207-320-89","62207-320-90"],"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":["62207-320","62207-321"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310965"],"spl_id":["5447b3da-b7bc-776b-e063-6394a90a1027"],"spl_set_id":["97516b9f-219a-429d-850d-1fe9fd66646b"],"substance_name":["IBUPROFEN"],"unii":["WK2XYI10QM"],"upc":["0362207321464","0362207320467"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL 62207-320-46-bottle 62207-320-46-carton 62207-320-91-bulk 62207-321-46-bottle 62207-321-46-carton 62207-321-91-bulk"],"pregnancy_or_breast_feeding":["IF PREGNANT OR BREAST FEEDING ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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":"97516b9f-219a-429d-850d-1fe9fd66646b","spl_product_data_elements":["IBUPROFEN IBUPROFEN SILICON DIOXIDE FD&C YELLOW NO. 6 STARCH, CORN POVIDONE K30 POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN G2 IBUPROFEN IBUPROFEN SILICON DIOXIDE FD&C YELLOW NO. 6 STARCH, CORN POVIDONE K30 POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN G2"],"spl_unclassified_section":["QUESTIONS OR COMMENTS Call 1-877-770-3183 weekdays 9:00 AM to 4:30 PM EST"],"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 ■ 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"],"storage_and_handling":["Other Information • store between 20° – 25°C (68 – 77°F). • do not use if neck wrap or foil inner seal is broken or missing"],"version":"7","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."],"when_using":["WHEN USING THIS PRODUCT ■ take with food or milk if stomach upset occurs"]}