{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *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 are taking a diuretic"],"ask_doctor_or_pharmacist":["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"],"do_not_use":["Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor"],"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 years: ask a doctor"],"effective_time":"20250716","id":"3a07455b-2d93-ed7f-e063-6394a90a45c2","inactive_ingredient":["Inactive ingredients carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, pregelatinized starch, povidone, sodium starch glycolate, stearic acid, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual and menstrual cramps"],"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 HEADACHE RELIEF"],"generic_name":["ACETAMINOPHEN ASPIRIN CAFFEINE"],"is_original_packager":[true],"manufacturer_name":["WAL-MART STORES INC"],"nui":["N0000000160","N0000008836","M0001335","N0000175722","N0000175578","N0000008832","N0000175739","N0000175729","N0000175790","M0023046"],"package_ndc":["79903-044-20","79903-044-42"],"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":["79903-044"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["308297"],"spl_id":["3a07455b-2d93-ed7f-e063-6394a90a45c2"],"spl_set_id":["d97073cd-b5d7-8c09-e053-2a95a90a8938"],"substance_name":["ASPIRIN","ACETAMINOPHEN","CAFFEINE"],"unii":["R16CO5Y76E","362O9ITL9D","3G6A5W338E"],"upc":["0681131409100"]},"other_safety_information":["Other information • store at 20°- 25°C (68°- 77°F) excursions permitted between 15°-30°C (59°-86°F) • use by expiration date on package"],"package_label_principal_display_panel":["370R-Walmart-HeadacheRelief-carton-label-24s.jpg 370R-Walmart-HeadacheRelief-bottle-label-24s.jpg 370R-Walmart-HeadacheRelief-bottle-label-200s"],"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 Pain reliever Pain reliever aid"],"questions":["Questions or comments? Call 1-877-290-4008"],"set_id":"d97073cd-b5d7-8c09-e053-2a95a90a8938","spl_product_data_elements":["EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN ASPIRIN CAFFEINE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE POVIDONE STEARIC ACID CARNAUBA WAX SODIUM STARCH GLYCOLATE TYPE A CORN TITANIUM DIOXIDE HYPROMELLOSES MINERAL OIL STARCH, CORN ASPIRIN ASPIRIN ACETAMINOPHEN ACETAMINOPHEN CAFFEINE CAFFEINE Capsule shaped tablet TCL370"],"spl_unclassified_section":["DRUG FACTS"],"stop_use":["Stop use and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better ringing in the ears or loss of hearing occurs, consult a doctor before taking any more of this product"],"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 • shock • asthma (wheezing) 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. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 caplets 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 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."]}