{"active_ingredient":["Active ingredient (in each tablet) Aspirin 81mg (NSAID)* *nonsteroidal anti-inflammatory drug"],"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 have asthma • you are taking a diuretic"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking a prescription drug for • gout • diabetes • arthritis"],"do_not_use":["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"],"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 exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years consult a doctor"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph> adults and children 12 years and over</paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph> take 4 to 8 tablets every 4 hours not exceed 48 tablets in 24 hours unless directed by a doctor</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph> children under 12 years</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph> consult a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20260514","id":"679c9b41-ae62-472e-bfbe-7f842da5da93","inactive_ingredient":["Inactive ingredients corn starch, dextrose monohydrate, FD&C yellow #6, orange flavor, silicon dioxide, sodium saccharine, stearic acid"],"indications_and_usage":["Uses • 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"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. (800-222-1222)."],"openfda":{"application_number":["M013"],"brand_name":["Aspirin Low Dose Chewable Orange"],"generic_name":["ASPIRIN"],"manufacturer_name":["Cardinal Health 107, LLC"],"nui":["N0000000160","N0000008836","M0001335","N0000175722","N0000175578","N0000008832"],"original_packager_product_ndc":["0904-7509"],"package_ndc":["55154-0191-0"],"pharm_class_cs":["Anti-Inflammatory Agents, Non-Steroidal [CS]"],"pharm_class_epc":["Nonsteroidal Anti-inflammatory Drug [EPC]","Platelet Aggregation Inhibitor [EPC]"],"pharm_class_moa":["Cyclooxygenase Inhibitors [MoA]"],"pharm_class_pe":["Decreased Prostaglandin Production [PE]","Decreased Platelet Aggregation [PE]"],"product_ndc":["55154-0191"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["318272"],"spl_id":["679c9b41-ae62-472e-bfbe-7f842da5da93"],"spl_set_id":["827bbe77-febb-4352-892f-3fbb2acfc7d5"],"substance_name":["ASPIRIN"],"unii":["R16CO5Y76E"],"upc":["0055154019101"]},"package_label_principal_display_panel":["Principal Display Panel NDC 55154-0191-0 ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER (NSAID) TABLETS 81 mg 10 CHEWABLE TABLETS 81mg bag label"],"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."],"purpose":["Purpose Pain reliever"],"questions":["Questions or comments? (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)"],"set_id":"827bbe77-febb-4352-892f-3fbb2acfc7d5","spl_product_data_elements":["Aspirin Low Dose Chewable Orange Aspirin ASPIRIN ASPIRIN STARCH, CORN DEXTROSE MONOHYDRATE FD&C YELLOW NO. 6 SILICON DIOXIDE SACCHARIN SODIUM STEARIC ACID PH;034"],"spl_unclassified_section":[". Overbagged with 10 chewable tablets per bag, NDC 55154-0191-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Packaged and Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number Distributed By: Cardinal Health Dublin, OH 43017 L6045991-10825 / L6045991-20825 Rev. 12/23 Re-order No. 701003 M-111"],"spl_unclassified_section_table":["<table width=\"100%\"><col width=\"33%\"/><col width=\"33%\"/><col width=\"33%\"/><tbody><tr styleCode=\"Toprule\"><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Rev. 12/23</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Re-order No. 701003</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>M-111</paragraph></td></tr></tbody></table>"],"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 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"],"storage_and_handling":["Other information • store at room temperature (15 0 -30 0 C) • Tamper Evident: do not use if safety seal under cap is broken or missing"],"version":"2","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 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. (800-222-1222)."]}