{"active_ingredient":["Active ingredients (in each caplet) ACETAMINOPHEN 250 MG ASPIRIN 250 MG (nsaid-nonsteroidal anti-inflammatory drug) CAFFEINE 65 MG"],"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. • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if • 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 Ask a doctor or pharmacist before use if you are • taking a prescription drug for diabetes, gout, or arthritis • taking any other drug or are under a doctor’s care for any serious condition 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 • ringing in the ears or loss of hearing occurs • painful area is red or swollen • pain gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days • 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."],"dosage_and_administration":["Directions • do not use more than directed • drink a full glass of water with each dose • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours • children under 12: ask a doctor"],"effective_time":"20241101","id":"bf365bfc-35cc-47f9-a50b-ff2b38d7316b","inactive_ingredient":["INACTIVE INGREDIENTS corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide"],"indications_and_usage":["USES"],"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 (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M013"],"brand_name":["EXTRA STRENGTH PAIN RELIEVER"],"generic_name":["ACETAMINOPHEN, ASPIRIN AND CAFFEINE"],"manufacturer_name":["Proficient Rx LP"],"nui":["N0000000160","N0000008836","M0001335","N0000175722","N0000175578","N0000008832","N0000175739","N0000175729","N0000175790","M0023046"],"original_packager_product_ndc":["57896-216"],"package_ndc":["82804-163-60"],"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":["82804-163"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308297"],"spl_id":["bf365bfc-35cc-47f9-a50b-ff2b38d7316b"],"spl_set_id":["bf365bfc-35cc-47f9-a50b-ff2b38d7316b"],"substance_name":["ACETAMINOPHEN","ASPIRIN","CAFFEINE"],"unii":["362O9ITL9D","R16CO5Y76E","3G6A5W338E"],"upc":["0382804163601"]},"other_safety_information":["Other information • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)"],"package_label_principal_display_panel":["Package label 82804-163-60"],"purpose":["Purposes PAIN RELIEVER - PAIN RELIEVER AID"],"questions":["Questions or comments? 1-800-540-3765"],"set_id":"bf365bfc-35cc-47f9-a50b-ff2b38d7316b","spl_product_data_elements":["EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, ASPIRIN AND CAFFEINE PROPYLENE GLYCOL SODIUM LAURYL SULFATE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE CROSPOVIDONE, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE STEARIC ACID CAPSULE SHAPED TABLET 44;334"],"version":"1","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 Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • rash • skin reddening • blisters If a skin reaction occurs, stop use and seek medical help right away. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • 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 • 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) • are age 60 or older • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed 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 heartbeat."]}