{ "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": [ "Aspirin 81mg Aspirin Enteric Coated Tablets 81mg TITANIUM DIOXIDE CROSCARMELLOSE SODIUM TRIETHYL CITRATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER D&C YELLOW NO. 10 FD&C YELLOW NO. 6 ASPIRIN ASPIRIN CELLULOSE, MICROCRYSTALLINE TALC STEARIC ACID SILICON DIOXIDE I1" ], "active_ingredient": [ "ACTIVE INGREDIENT Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflamatory drug" ], "purpose": [ "PURPOSE Pain reliever" ], "indications_and_usage": [ "USES Temporarily relieves minor aches and pains For use as directed by a doctor for the prevention of recurrent heart attack or stroke Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief." ], "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." ], "other_safety_information": [ "ALLERGY ALERT Allergy Alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock" ], "spl_unclassified_section": [ "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 non-prescription NSAIDs(aspirin, ibuprofen, naproxen, 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 SECTION Do not use if: You are allergic to aspirin or any other pain reliever/fever reducer." ], "ask_doctor_or_pharmacist": [ "ASK A DOCTOR/PHARMACIST Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis" ], "stop_use": [ "STOP USE SECTION 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 new symptoms occur ringing in the ears or loss of hearing occurs." ], "pregnancy_or_breast_feeding": [ "PREGNANCY OR BREAST FEEDING SECTION If pregnant or breast-feeding, ask a health professional. 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 SECTION 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 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" ], "storage_and_handling": [ "STORAGE Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F–86°F) Use by expiration date on package." ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Microcrystalline Cellulose, Talc, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Titanium Dioxide, Triethyl Citrate, Methacrylic Acid and Ethyl Acrylate Copolymer, D&C Yellow #10, FD&C Yellow #6" ], "ask_doctor": [ "ASK A DOCTOR BEFORE USE Stomach bleeding warning applies to you You have a history of stomach problems, such as heartburn You have a high blood pressure, heart disease, liver cirrhosis, or kidney disease You are taking a diuretic You have asthma" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 60577-808-01 Vitane's Aspirin 81mg Pain Reliever Aspirin 81 mg (NSAID) Enteric Coated 60 tablets Aspirin 81mg Label ASPIRIN 81 mg IFC" ], "set_id": "41386de5-5857-efab-e063-6294a90afd9c", "id": "41386de5-5858-efab-e063-6294a90afd9c", "effective_time": "20251015", "version": "1", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Aspirin 81mg" ], "generic_name": [ "ASPIRIN ENTERIC COATED TABLETS 81MG" ], "manufacturer_name": [ "VITANE PHARMACEUTICALS, INC" ], "product_ndc": [ "60577-808" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ASPIRIN" ], "rxcui": [ "308416" ], "spl_id": [ "41386de5-5858-efab-e063-6294a90afd9c" ], "spl_set_id": [ "41386de5-5857-efab-e063-6294a90afd9c" ], "package_ndc": [ "60577-808-01" ], "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" ] } } ] }