{"active_ingredient":["ACTIVE INGREDIENT (in each tablet/caplet) 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 take more than directed the smallest effective dose should be used adults and children 12 years and older 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":["<table border=\"1\" frame=\"void\" width=\"589\"><tbody><tr><td styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\">adults and children 12 years and older</td><td styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><list listType=\"unordered\" styleCode=\"Disc\"><item>take 1 caplet every 4 to 6 hours while symptoms persist</item><item>if pain or fever does not respond to 1 caplet, 2 caplets may be used</item><item>do not exceed 6 caplets in 24 hours, unless directed by a doctor</item></list></td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\">children under 12 years</td><td styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><list listType=\"unordered\" styleCode=\"Disc\"><item>ask a doctor</item></list></td></tr></tbody></table>"],"effective_time":"20240813","id":"1f8c5711-4342-d41b-e063-6394a90acb7a","inactive_ingredient":["INACTIVE INGREDIENTS colloidal silicon dioxide, iron oxide red, maize starch, poly ethylene glycol, povidone k-30, 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":["ANDA079174"],"brand_name":["Ibuprofen"],"generic_name":["IBUPROFEN"],"is_original_packager":[true],"manufacturer_name":["Granules India Limited"],"nui":["N0000000160","M0001335","N0000175722"],"package_ndc":["62207-365-51","62207-365-41","62207-365-42","62207-365-43","62207-365-46","62207-365-47","62207-365-48","62207-365-49","62207-366-51","62207-366-41","62207-366-42","62207-366-43","62207-366-46","62207-366-47","62207-366-48","62207-366-49","62207-396-51","62207-396-41","62207-396-42","62207-396-43","62207-396-46","62207-396-47","62207-396-48","62207-396-49","62207-395-51","62207-395-41","62207-395-42","62207-395-43","62207-395-46","62207-395-47","62207-395-48","62207-395-49"],"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":["62207-365","62207-366","62207-396","62207-395"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310965"],"spl_id":["1f8c5711-4342-d41b-e063-6394a90acb7a"],"spl_set_id":["fd01353d-1d1d-42b5-9a03-575052189bf5"],"substance_name":["IBUPROFEN"],"unii":["WK2XYI10QM"],"upc":["0362207396462"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC# 62207-366-46 See New Warnings Information IBUPROFEN TABLETS USP, 200 mg Pain Reliever/Fever Reducer (NSAID)* Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye) Do not use if foil inner seal is broken or missing. 250 Coated Caplets † † Capsule-Shaped Tablets Important: Read all product information before using. Do not use if the foil inner seal is broken or missing NDC# 62207-366-47 Do not use if the foil inner seal is broken or missing See New Warnings Information IBUPROFEN TABLETS USP, 200 mg Pain Reliever/Fever Reducer (NSAID)* Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye) Do not use if foil inner seal is broken or missing. 500 Coated Caplets† †Capsule-Shaped Tablets Important: Read all product information before using. NDC# 62207-396-46 See New Warnings Information IBUPROFEN TABLETS USP, 200 mg Pain Reliever/Fever Reducer (NSAID)* Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye) Do not use if foil inner seal is broken or missing. 250 Coated Caplets† †Capsule-Shaped Tablets Important: Read all product information before using. NDC# 62207-396-46 Do not use if the foil inner seal is broken or missing See New Warnings Information IBUPROFEN TABLETS USP, 200 mg Pain Reliever/Fever Reducer (NSAID)* Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye) Do not use if foil inner seal is broken or missing. 500 Coated Caplets† †Capsule-Shaped Tablets Important: Read all product information before using. ibu-366-250ct-carton.jpg ibu-366-500ct-label.jpg ibu-396-250ct-carton.jpg ibu-396-250ct-label.jpg"],"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"],"questions":["QUESTIONS OR COMMENTS? Call 1-877-770-3183: weekdays 9:00 AM to 4:30 PM EST"],"recent_major_changes":[""],"set_id":"fd01353d-1d1d-42b5-9a03-575052189bf5","spl_product_data_elements":["Ibuprofen Ibuprofen STARCH, CORN POVIDONE K30 STEARIC ACID SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE FERRIC OXIDE RED IBUPROFEN IBUPROFEN TALC POLYETHYLENE GLYCOL 3350 Reddish Brown G;2 Ibuprofen Ibuprofen POLYETHYLENE GLYCOL 3350 STARCH, CORN POVIDONE K30 STEARIC ACID SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE FERRIC OXIDE RED IBUPROFEN IBUPROFEN TALC Reddish Brown (Capsule shaped tablet) G;2 Ibuprofen Ibuprofen STARCH, CORN POVIDONE K30 STEARIC ACID SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE FERRIC OXIDE RED IBUPROFEN IBUPROFEN POLYETHYLENE GLYCOL 3350 TALC Reddish Brown (Capsule shaped tablet) G;2 Ibuprofen Ibuprofen STARCH, CORN POVIDONE K30 STEARIC ACID SILICON DIOXIDE IBUPROFEN IBUPROFEN SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE FERRIC OXIDE RED TALC POLYETHYLENE GLYCOL 3350 Reddish Brown G;2"],"spl_unclassified_section":["Drug Facts","Other Information store at 20-25°C (68-77°F)[See USP Controlled Room Temperature] avoid high humidity and excessive heat above 40°C (104°F)","Manufactured By: Granules India Limited Hyderabad – 500 043, India MADE IN INDIA M.L.No: 37/RR/AP/2003/F/R Distributed By: Granules USA, Inc. Parsippany, NJ 07054"],"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":"19","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"]}