{ "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": [ "Low dose Aspirin Aspirin 81 mg Delayed Release Tablets DIMETHICONE ANHYDROUS LACTOSE SILICON DIOXIDE MICROCRYSTALLINE CELLULOSE SODIUM HYDROXIDE FERRIC OXIDE RED TALC SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE ASPIRIN ASPIRIN CARNAUBA WAX D&C YELLOW NO. 10 ALUMINUM LAKE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER TRIETHYL CITRATE CROSCARMELLOSE SODIUM POLYSORBATE 80 Heart" ], "spl_unclassified_section": [ "DRUG FACTS" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ], "purpose": [ "Purpose Pain reliever" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for enteric-coated 81 mg Aspirin" ], "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 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 problem take a blood thinning (anticoagulant) or steroid drug take other drug 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 you have asthma stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease" ], "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 fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur ringing in the ears or a loss of hearing occurs" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, 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 (1-800-222-1222) right away." ], "dosage_and_administration": [ "Directions drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor" ], "other_safety_information": [ "Other information Store at room temperature. Avoid excessive heat above 40°C (104°F)." ], "inactive_ingredient": [ "Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate" ], "questions": [ "Questions or comments? Call 1-877-290-4008" ], "package_label_principal_display_panel": [ "481R-walg 32ct IFC 481R-walg 32ct label 481R-walg 120ct IFC 481R-walg 120ct label 481R-walg 200ct IFC 481R-walg 200ct label 481R-walg 300ct IFC 481R-walg 300ct label" ], "set_id": "c25c3524-3e24-3410-e053-2995a90a73ed", "id": "2cea1dfd-7b3e-9c49-e063-6394a90a29a1", "effective_time": "20250130", "version": "5", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Low dose Aspirin" ], "generic_name": [ "ASPIRIN 81 MG DELAYED RELEASE TABLETS" ], "manufacturer_name": [ "WALGREENS" ], "product_ndc": [ "0363-0690" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ASPIRIN" ], "rxcui": [ "308416" ], "spl_id": [ "2cea1dfd-7b3e-9c49-e063-6394a90a29a1" ], "spl_set_id": [ "c25c3524-3e24-3410-e053-2995a90a73ed" ], "package_ndc": [ "0363-0690-12", "0363-0690-32", "0363-0690-29", "0363-0690-20", "0363-0690-31" ], "is_original_packager": [ true ], "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" ] } } ] }