{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Ibuprofen Immediate Release Ibuprofen IBUPROFEN IBUPROFEN SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE TRIACETIN FD&C YELLOW NO. 6 TALC Round shaped IBU200 Ibuprofen Immediate Release Ibuprofen IBUPROFEN IBUPROFEN SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STARCH, CORN TITANIUM DIOXIDE TRIACETIN FD&C YELLOW NO. 6 TALC HYPROMELLOSE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO capsule shaped IBU200" ], "boxed_warning": [ "Important: Read all product information before using. Keep the box for important information." ], "active_ingredient": [ "Active ingredient (in each Orange tablet or caplet ** ) Ibuprofen 200 mg (NSAID) * * nonsteroidal anti-inflammatory drug **capsule-shaped tablets" ], "purpose": [ "Purpose Pain reliever / fever reducer" ], "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" ], "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": [ "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_doctor_or_pharmacist": [ "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" ], "spl_unclassified_section": [ "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", "Directions do not take 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", "Manufactured by: Strides Pharma Science Limited , Puducherry - 605 014, India. PON/DRUGS/16 13 4193 Distributed by: Strides Pharma Inc . Bridgewater, NJ 08807 September 2026" ], "when_using": [ "When using this product take with food or milk if stomach upset occurs" ], "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" ], "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." ], "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)" ], "spl_unclassified_section_table": [ "
adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persistif pain or fever does not respond to 1 tablet, 2 tablets may be useddo not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years ask a doctor
" ], "storage_and_handling": [ "Other Information store between 20-25 0 C (68-77 0 F) do not use if carton is opened. Do not use if foil inner seal imprinted with \"Sealed For Your Safety\" is broken or missing" ], "inactive_ingredient": [ "Inactive Ingredients colloidal silicon dioxide, corn starch, D&C yellow no.10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide, and triacetin" ], "questions": [ "Questions or Comments Call 1-877-244-9825 (toll-free)" ], "dosage_and_administration": [ "" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL label label" ], "set_id": "ebcc4da3-d0f6-4e40-99b5-e88310ea4a5b", "id": "71d99813-1855-484f-a71b-333fcb701a77", "effective_time": "20260902", "version": "4", "openfda": { "application_number": [ "ANDA091355" ], "brand_name": [ "Ibuprofen Immediate Release" ], "generic_name": [ "IBUPROFEN" ], "manufacturer_name": [ "Strides Pharma Inc" ], "product_ndc": [ "59556-855", "59556-856" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "IBUPROFEN" ], "rxcui": [ "310965" ], "spl_id": [ "71d99813-1855-484f-a71b-333fcb701a77" ], "spl_set_id": [ "ebcc4da3-d0f6-4e40-99b5-e88310ea4a5b" ], "package_ndc": [ "59556-855-42", "59556-856-42" ], "is_original_packager": [ true ], "nui": [ "N0000000160", "M0001335", "N0000175722" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ], "unii": [ "WK2XYI10QM" ] } } ] }