{"active_ingredient":["Active ingredient (in each caplet) Acetaminophen 500mg"],"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 take for more than 10 days unless directed by a doctor children under 12 years ask a doctor"],"dosage_and_administration_table":["<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"50%\"> <tbody> <tr> <td valign=\"top\"> <paragraph>adults and children 12 years and over</paragraph> </td> <td valign=\"top\"> <list listType=\"unordered\"> <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 take for more than 10 days unless directed by a doctor</item> </list> </td> </tr> <tr> <td valign=\"top\"> <paragraph>children under 12 years</paragraph> </td> <td valign=\"top\"> <paragraph>ask a doctor</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20190624","how_supplied":["HOW SUPPLIED Product: 50090-1191 NDC: 50090-1191-0 40 TABLET, COATED in a BOTTLE"],"id":"8cd7dffe-2621-4b26-b679-4bb7ae028434","inactive_ingredient":["Inactive ingredients hypromellose, povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid, talc, triacetin"],"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":{},"overdosage":["Overdose warning: In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"],"package_label_principal_display_panel":["Acetaminophen 500mg 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? Adverse drug event call: (866) 562-2756 Mon - Fri 8 AM to 4 PM"],"set_id":"622b3838-9ecf-481d-bf4b-4ca0ffa77492","spl_product_data_elements":["PHARBETOL Acetaminophen 500mg ACETAMINOPHEN ACETAMINOPHEN HYPROMELLOSE, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TALC TRIACETIN Capsule Shaped Tablet (Caplet) PH016"],"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 Tamper Evident: do not use if imprinted safety seal under cap is broken or missing store between 20 o -25 o C (68 o -77 o F)"],"version":"1","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets 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 the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"]}