{"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":["<table width=\"100%\"> <col width=\"25%\"/> <col width=\"75%\"/> <tbody> <tr> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>adults and children 12 years and over</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <list listType=\"unordered\"> <item> <caption>&#x2022;</caption>take 2 caplets every 8 hours with water</item> <item> <caption>&#x2022;</caption>swallow whole &#x2013; do not crush, chew, split or dissolve</item> <item> <caption>&#x2022;</caption>do not take more than 6 caplets in 24 hours</item> <item> <caption>&#x2022;</caption>do not use for more than 10 days unless directed by a doctor</item> </list> </td> </tr> <tr> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>children under 12 years</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <list listType=\"unordered\"> <item> <caption>&#x2022;</caption>do not use</item> </list> </td> </tr> </tbody> </table>"],"effective_time":"20190822","id":"bc87abb3-fed2-44ea-8577-412cc2290700","inactive_ingredient":["Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide"],"indications_and_usage":["Uses • temporarily relieves minor aches and pains due to: • muscular aches • backache • headache • minor pain of arthritis • temporarily reduces fever"],"keep_out_of_reach_of_children":["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."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel COMPARE TO the active ingredient of TYLENOL® 8HR See end panel SEE NEW WARNING Acetaminophen 8 HOUR Extended Release Tablets, 650 mg Pain Reliever/Fever Reducer EXTENDED-RELEASE For Up to 8 Hour Relief of Minor Muscle Aches and Pain Headache/Backache/Minor Pain of Arthritis actual size CAPLETS* - 650 mg 100 EACH *(capsule-shaped tablets) Acetaminophen 8 Hour Image 1 Acetaminophen 8 Hour Image 2"],"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? 1-800-632-6900"],"set_id":"05ff95ab-ef1d-44f7-863e-3d6c6458af0b","spl_product_data_elements":["acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL POLYSORBATE 80 POVIDONE STEARIC ACID TITANIUM DIOXIDE L217"],"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 at 20-25 ° C (68-77 ° F). Avoid excessive heat 40 ° C (104 ° F)."],"version":"4","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."]}