{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "BAYER Aspirin Extra Strength Caplets BAYER Aspirin Extra Strength CARNAUBA WAX STARCH, CORN D&C RED NO. 7 ALUMINUM OXIDE FD&C BLUE NO. 2 FD&C RED NO. 40 HYPROMELLOSES POWDERED CELLULOSE PROPYLENE GLYCOL SHELLAC TITANIUM DIOXIDE TRIACETIN ASPIRIN ASPIRIN Extra;Strength;BAYER" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredient (in each caplet) Aspirin 500 mg (NSAID) nonsteroidal anti-inflammatory drug" ], "purpose": [ "Pain reliever/fever reducer" ], "indications_and_usage": [ "Uses temporarily relieves headache pain and fever of colds muscle pain menstrual pain toothache minor pain of arthritis" ], "warnings": [ "Warnings Reye’s syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert : Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warni ng: 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": [ "Do not use if you are allergic to aspirin or any other pain reliever/fever reducer if you have ever had an allergic reaction to this product or any of its ingredients" ], "ask_doctor": [ "Ask a doctor before use if 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, or kidney disease you are taking a diuretic you have asthma" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. 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 redness or swelling is present fever lasts more than 3 days new symptoms occur ringing in the ears or a loss of hearing occurs" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feedin g, ask a health professional before use. It is especially important not to use aspirin 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": [ "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 drink a full glass of water with each dose adults and children 12 years and over: take 1 or 2 caplets every 4 to 6 hours not to exceed 8 caplets in 24 hours children under 12 years: consult a doctor" ], "other_safety_information": [ "Other Information save carton for full directions and warnings store at room temperature. Avoid excessive heat above 40ºC (104ºF)." ], "inactive_ingredient": [ "Inactive ingredients carnauba wax, corn starch, D&C red #7 calcium lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, powdered cellulose, propylene glycol, shellac, titanium dioxide, triacetin" ], "questions": [ "Questions or comments? 1-800-331-4536 (Mon – Fri 9AM – 5PM EST)" ], "package_label_principal_display_panel": [ "Carton 100 caplets Carton" ], "set_id": "0ae64cdb-4ea0-23af-e054-00144ff88e88", "id": "4526b08f-a640-90b9-e063-6294a90a1189", "effective_time": "20251204", "version": "6", "openfda": { "application_number": [ "M013" ], "brand_name": [ "BAYER Aspirin Extra Strength Caplets" ], "generic_name": [ "BAYER ASPIRIN EXTRA STRENGTH" ], "manufacturer_name": [ "Bayer HealthCare LLC." ], "product_ndc": [ "0280-2020" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ASPIRIN" ], "rxcui": [ "198471", "211887" ], "spl_id": [ "4526b08f-a640-90b9-e063-6294a90a1189" ], "spl_set_id": [ "0ae64cdb-4ea0-23af-e054-00144ff88e88" ], "package_ndc": [ "0280-2020-10" ], "is_original_packager": [ true ], "upc": [ "0312843555075" ], "nui": [ "N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Prostaglandin Production [PE]", "Decreased Platelet Aggregation [PE]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]" ], "unii": [ "R16CO5Y76E" ] } } ] }