{"active_ingredient":["Drug Facts Active ingredients (in each tablet) Acetaminophen USP 250 mg Aspirin USP 250 mg (NSAID*) Caffeine USP 65 mg *nonsteroidal anti-inflammatory drug"],"ask_doctor":["Ask a doctor before use if • you have never had migraines diagnosed by a health professional • you have a headache that is different from your usual migraines • you have the worst headache of your life • you have fever and stiff neck • you have headaches beginning after or caused by head injury, exertion, coughing or bending • you experienced your first headache after the age of 50 • you have daily headaches • you have a migraine so severe as to require bed rest • you have liver disease • 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 • you have problems or serious side effects from taking pain relievers or fever reducers • you have vomiting with your migraine headache"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are • taking a prescription drug for: • diabetes • gout • arthritis • under a doctor’s care for any serious condition • taking any other drug • taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer"],"do_not_use":["Do not use • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist"],"dosage_and_administration":["Directions do not use more than directed adults: take 2 tablets with a glass of water if symptoms persist or worsen, ask your doctor do not take more than 2 tablets in 24 hours, unless directed by a doctor under 18 years of age: ask a doctor"],"effective_time":"20230511","id":"663a4a3d-c77c-44a8-a082-ee65baf3c6af","inactive_ingredient":["Inactive ingredients crospovidone, glyceryl monostearate, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch (maize), sodium lauryl sulfate, stearic acid, talc and titanium dioxide."],"indications_and_usage":["Use treats migraine"],"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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["ANDA211695"],"brand_name":["ACETAMINOPHEN ASPIRIN AND CAFFEINE"],"generic_name":["ACETAMINOPHEN, ASPIRIN AND CAFFEINE"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"nui":["N0000000160","N0000008836","M0001335","N0000175722","N0000175578","N0000008832","N0000175739","N0000175729","N0000175790","M0023046"],"package_ndc":["58602-817-02","58602-817-03","58602-817-07","58602-817-09","58602-817-14","58602-817-21","58602-817-90","58602-817-34","58602-817-36","58602-817-38"],"pharm_class_cs":["Anti-Inflammatory Agents, Non-Steroidal [CS]","Xanthines [CS]"],"pharm_class_epc":["Nonsteroidal Anti-inflammatory Drug [EPC]","Platelet Aggregation Inhibitor [EPC]","Central Nervous System Stimulant [EPC]","Methylxanthine [EPC]"],"pharm_class_moa":["Cyclooxygenase Inhibitors [MoA]"],"pharm_class_pe":["Decreased Prostaglandin Production [PE]","Decreased Platelet Aggregation [PE]","Central Nervous System Stimulation [PE]"],"product_ndc":["58602-817"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308297"],"spl_id":["663a4a3d-c77c-44a8-a082-ee65baf3c6af"],"spl_set_id":["e47e2169-4b31-4c23-bb9d-c26aa106ea37"],"substance_name":["ACETAMINOPHEN","ASPIRIN","CAFFEINE"],"unii":["362O9ITL9D","R16CO5Y76E","3G6A5W338E"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Label - 8 Tablets AUROHEALTH NDC 58602-817-02 MIGRAINE RELIEF Acetaminophen, Aspirin (NSAID) and Caffeine Tablets USP 250 mg/250 mg/65 mg Pain Reliever/ Pain Reliever Aid 8 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Label - 8 Tablets","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Carton Label - 8 Tablets AUROHEALTH NDC 58602-817-02 **Compare to the active ingredients of Excedrin® Migraine Relief MIGRAINE RELIEF Acetaminophen, Aspirin (NSAID) and Caffeine Tablets USP 250 mg/250 mg/65 mg Do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing. Pain Reliever/Pain Reliever Aid 8 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/250 mg/65 mg Container Carton Label - 8 Tablets"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery."],"purpose":["Purposes Pain reliever Pain reliever Pain reliever aid"],"questions":["Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016"],"set_id":"e47e2169-4b31-4c23-bb9d-c26aa106ea37","spl_product_data_elements":["ACETAMINOPHEN ASPIRIN AND CAFFEINE acetaminophen, aspirin and caffeine ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE CROSPOVIDONE (120 .MU.M) GLYCERYL MONOSTEARATE LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE K30 POVIDONE K90 STARCH, CORN SODIUM LAURYL SULFATE STEARIC ACID TALC TITANIUM DIOXIDE White to off-White biconvex T;57"],"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 • your migraine is not relieved or worsens after first dose • new or unexpected symptoms occur • ringing in the ears or loss of hearing occurs"],"storage_and_handling":["Other information store at controlled room temperature 20°-25°C (68°-77°F) close cap tightly after use read all product information before using. Keep this box for important information."],"version":"3","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: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash. If a skin reaction occurs, stop use and seek medical help right away. Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 2 tablets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product. 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 Medication overuse headache warning: Headaches may worsen if this product is used for 10 or more days per month. Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat."]}