{ "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": "2026-06-09", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "Advil ibuprofen sodium ACESULFAME POTASSIUM CARAMEL CARNAUBA WAX SILICON DIOXIDE COPOVIDONE K25-31 FERRIC OXIDE RED HYPROMELLOSE, UNSPECIFIED MANNITOL MEDIUM-CHAIN TRIGLYCERIDES MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL SODIUM LAURYL SULFATE SUCRALOSE TITANIUM DIOXIDE IBUPROFEN SODIUM IBUPROFEN beige Advil;asymmetrical;underline Advil ibuprofen sodium ACESULFAME POTASSIUM CARAMEL CARNAUBA WAX SILICON DIOXIDE COPOVIDONE K25-31 FERRIC OXIDE RED HYPROMELLOSE, UNSPECIFIED MANNITOL MEDIUM-CHAIN TRIGLYCERIDES MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL SODIUM LAURYL SULFATE SUCRALOSE TITANIUM DIOXIDE IBUPROFEN SODIUM IBUPROFEN beige Advil;asymmetrical;underline" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 200 mg (provided as ibuprofen sodium 256 mg) (NSAID)* *nonsteroidal anti-inflammatory drug" ], "purpose": [ "Purpose Pain reliever/ Fever reducer" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis 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 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, asthma, or had a stroke 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 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 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. In case of overdose, get medical help or contact a Poison Control Center right away." ], "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" ], "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, asthma, or had a stroke 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" ], "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." ], "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: 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" ], "storage_and_handling": [ "Other information each tablet contains: sodium 22 mg read all warnings and directions before use. store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, caramel color, carnauba wax, colloidal silicon dioxide, copovidone, ferric oxide, hypromellose, mannitol, medium-chain triglycerides, microcrystalline cellulose, natural and artificial flavor, pharmaceutical ink, polyethylene glycol, propylene glycol, sodium lauryl sulfate, sucralose, titanium dioxide" ], "questions": [ "Questions or comments? Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL" ], "spl_unclassified_section": [ "Additional Information Do Not Use if the sealed child resistant pouch is broken or torn. For most recent product information, visit www.Advil.com" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Advil FILM-COATED IBUPROFEN SODIUM Ibuprofen Tablets, 200 mg (Provided as Ibuprofen Sodium 256 mg) Pain Reliever / Fever Reducer (NSAID) Advil Tablets Headache Muscular Aches Minor Pain of Arthritis Menstrual Cramps Toothache Fever See Full Drug Facts information on the back of this dispenser 100 TABLETS (50 PACKETS of 2 TABLETS EACH) 000068427 Front Carton Advil Ibuprofen Tablets 100 ct", "PRINCIPAL DISPLAY PANEL Advil ® 20 FREE TABLETS Ibuprofen Tablets, 200 mg (Provided as Ibuprofen Sodium 256 mg) Pain Reliever / Fever Reducer (NSAID) FILM-COATED IBUPROFEN SODIUM Advil Tablets 100 Tablets Advil Ibuprofen Tablets 100 ct" ], "set_id": "5be198b8-396e-4b44-8819-e2e3b5d2ad0e", "id": "40429ef4-846a-eb4c-e063-6394a90ab7a9", "effective_time": "20251003", "version": "20", "openfda": { "application_number": [ "NDA201803" ], "brand_name": [ "Advil" ], "generic_name": [ "IBUPROFEN SODIUM" ], "manufacturer_name": [ "Haleon US Holdings LLC" ], "product_ndc": [ "0573-0133", "0573-0134" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "IBUPROFEN SODIUM" ], "rxcui": [ "153008", "310965" ], "spl_id": [ "40429ef4-846a-eb4c-e063-6394a90ab7a9" ], "spl_set_id": [ "5be198b8-396e-4b44-8819-e2e3b5d2ad0e" ], "package_ndc": [ "0573-0133-20", "0573-0133-40", "0573-0133-80", "0573-0133-02", "0573-0133-04", "0573-0133-89", "0573-0133-81", "0573-0133-05", "0573-0133-88", "0573-0133-41", "0573-0133-91", "0573-0133-01", "0573-0134-20", "0573-0134-80" ], "is_original_packager": [ true ], "unii": [ "RM1CE97Z4N" ] } } ] }