{"active_ingredient":["Active ingredient (in each caplet) Acetaminophen 650 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 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor children under 12 years do not use"],"dosage_and_administration_table":["
adults and children 12 years and overtake 2 caplets every 8 hours with waterswallow whole; do not crush, chew, split or dissolvedo not take more than 6 caplets in 24 hoursdo not use for more than 10 days unless directed by a doctor
children under 12 yearsdo not use
"],"effective_time":"20241107","id":"21e84490-8cad-bf34-e063-6394a90af940","inactive_ingredient":["Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, povidone, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin"],"indications_and_usage":["Uses temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["NDA019872"],"brand_name":["Tylenol 8HR"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["Kenvue Brands LLC"],"package_ndc":["50580-309-01","50580-309-02"],"product_ndc":["50580-309"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1148399","1243440"],"spl_id":["21e84490-8cad-bf34-e063-6394a90af940"],"spl_set_id":["5d7d1300-bcb8-466a-880b-310b360ee132"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"],"upc":["0300450297211"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 50580-309-02 TYLENOL ® 8HR MUSCLE ACHES & PAIN Acetaminophen Extended-release tablets Pain Reliever / Fever Reducer For Up to 8 Hours Relief of Minor Muscle Aches & Pain *Capsule-Shaped Bi-Layer Tablets Actual Size 100 Caplets* 650 mg each Principal Display Panel"],"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":"5d7d1300-bcb8-466a-880b-310b360ee132","spl_product_data_elements":["Tylenol 8HR acetaminophen CARNAUBA WAX HYDROXYETHYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED POWDERED CELLULOSE SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE TRIACETIN ACETAMINOPHEN ACETAMINOPHEN TYLENOL;ER"],"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 6 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 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."]}