{ "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": [ "ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER ASPIRIN ASPIRIN STEARIC ACID SILICON DIOXIDE DEXTROSE MONOHYDRATE STARCH, CORN FD&C YELLOW NO. 6 SACCHARIN SODIUM PH034" ], "active_ingredient": [ "ACTIVE INGREDIENT [IN EACH TABLET] Aspirin 81mg (NSAID)* *nonsteroidal anti-inflammatory drug" ], "purpose": [ "Pain reliever" ], "spl_unclassified_section": [ "USES for the temporary relief of minor aches and pains or as recommended by your doctor ask your doctor about other uses for Chewable Aspirin 81 mg", "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 exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years consult a doctor", "OTHER INFORMATION store at room temperature (150-300C) Tamper Evident: do not use if safety seal under cap is broken or missing" ], "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 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 if you are allergic to aspirin or any other pain reliever/fever reducer for at least 7 days after tonsillectomy or oral surgery unless directed by a 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 have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis 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 get worse or lasts more than 3 days redness or swelling is present ringing in the ears or loss of hearing occurs any new symptoms occur These could be signs of a serious condition 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. In case of accidental overdose, get medical help or contact a Poison Control Center right away." ], "inactive_ingredient": [ "corn starch, dextrose monohydrate, FD&C yellow #6, orange flavor, silicon dioxide, sodium saccharine, stearic acid" ], "questions": [ "1-800-616-2471" ], "dosage_and_administration": [ "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 exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years consult a doctor" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN" ], "indications_and_usage": [ "for the temporary relief of minor aches and pains or as recommneded by your doctor ask your doctor about other uses for Chewable Aspirin 81 mg" ], "package_label_principal_display_panel": [ "BOTTLE LABEL RFID Label" ], "set_id": "13e621dc-b2b4-98fd-e063-6394a90acc75", "id": "13e621dc-b2b5-98fd-e063-6394a90acc75", "effective_time": "20240317", "version": "1", "openfda": { "application_number": [ "M013" ], "brand_name": [ "ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER" ], "generic_name": [ "ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER" ], "manufacturer_name": [ "HF Acquisition Co LLC, DBA HealthFirst" ], "product_ndc": [ "51662-1356" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ASPIRIN" ], "rxcui": [ "318272" ], "spl_id": [ "13e621dc-b2b5-98fd-e063-6394a90acc75" ], "spl_set_id": [ "13e621dc-b2b4-98fd-e063-6394a90acc75" ], "package_ndc": [ "51662-1356-1" ], "original_packager_product_ndc": [ "0904-6794" ], "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" ] } } ] }