{"active_ingredient":["Active ingredient (in each caplet) Acetaminophen 500 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin"],"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. if you are allergic to acetaminophen or any of the inactive ingredients in this product"],"dosage_and_administration":["Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor"],"dosage_and_administration_table":["<table width=\"60%\" styleCode=\"Noautorules\"><col width=\"30%\" align=\"left\" valign=\"top\"/><col width=\"70%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Toprule Rrule\">adults and children 12 years and over</td><td styleCode=\"Toprule\"><list listType=\"unordered\" styleCode=\"Square\"><item>take 2 caplets every 6 hours while symptoms last</item><item>do not take more than 6 caplets in 24 hours, unless directed by a doctor</item><item>do not use for more than 10 days unless directed by a doctor</item></list></td></tr><tr><td styleCode=\"Rrule\">children under 12 years</td><td>ask a doctor</td></tr></tbody></table>"],"effective_time":"20240517","how_supplied":["HOW SUPPLIED Product: 50090-5469 NDC: 50090-5469-0 24 TABLET, FILM COATED in a BOTTLE / 1 in a CARTON"],"id":"72fb757a-ac68-4800-bdc0-ace18841ef75","inactive_ingredient":["Inactive ingredients carnauba wax contains one or more of these ingredients , corn starch , FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch , polyethylene glycol , powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M013"],"brand_name":["TYLENOL EXTRA STRENGTH"],"generic_name":["ACETAMINOPHEN"],"manufacturer_name":["A-S Medication Solutions"],"original_packager_product_ndc":["50580-937"],"package_ndc":["50090-5469-0"],"product_ndc":["50090-5469"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198440","209459"],"spl_id":["72fb757a-ac68-4800-bdc0-ace18841ef75"],"spl_set_id":["bcb7eb24-16cb-439e-879f-48d2f5e8ba83"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"package_label_principal_display_panel":["ACETAMINOPHEN Label Image"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer"],"questions":["Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)"],"set_id":"bcb7eb24-16cb-439e-879f-48d2f5e8ba83","spl_product_data_elements":["TYLENOL EXTRA STRENGTH Acetaminophen CARNAUBA WAX STARCH, CORN FD&C RED NO. 40 ALUMINUM OXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POWDERED CELLULOSE PROPYLENE GLYCOL SHELLAC SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN RED PRINT TYLENOL;500"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition."],"storage_and_handling":["Other information store between 20-25°C (68-77°F) do not use if carton is opened. Do not use if foil inner seal imprinted with \"TYLENOL\" is broken or missing"],"version":"9","warnings":["Warnings 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 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. 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. if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning 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."]}