{"active_ingredient":["Active Ingredient (in each rectal suppository) Acetaminophen 325 mg"],"dosage_and_administration":["DIRECTIONS • do not use more than directed • remove foil wrapper • insert suppository well up into rectum children under 6 years do not use children 6-12 years 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours) adults and children 12 years and older 2 suppositories every 4 to 6 hours (maximum of 6 doses)"],"dosage_and_administration_table":["<table border=\"1\" cellpadding=\"4\" cellspacing=\"0\"><tbody><tr><td styleCode=\"Botrule Lrule Rrule Toprule\"><content styleCode=\"bold\">children under 6 years</content></td><td styleCode=\"Botrule Lrule Rrule Toprule\"><content styleCode=\"bold\">do not use</content></td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\">children 6-12 years</td><td styleCode=\"Botrule Lrule Rrule Toprule\">1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\">adults and children 12 years and older</td><td styleCode=\"Botrule Lrule Rrule Toprule\">2 suppositories every 4 to 6 hours (maximum of 6 doses)</td></tr></tbody></table>"],"effective_time":"20220420","id":"dd1b1864-603d-2c53-e053-2a95a90ac7ec","inactive_ingredient":["INACTIVE INGREDIENTS glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate"],"indications_and_usage":["USES temporarily • reduces fever • relieves minor aches, pains, and headache"],"keep_out_of_reach_of_children":["Other Information • store at room temperature 15˚-30˚C (59˚-86˚F) • do not use if imprinted suppository wrapper is opened or damaged"],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 0713-0164-01 ACEPHEN TM ACETAMINOPHEN SUPPOSITORIES USP 325 mg Pain Reliever • Fever Reducer 100 Rectal Suppositories 100 count"],"purpose":["PURPOSE Pain reliever/fever reducer"],"questions":["QUESTIONS ? call 1-800-922-1038"],"set_id":"20fae2ab-fcce-b026-be00-d9aa2f396f7d","spl_product_data_elements":["ACEPHEN Acetaminophen GLYCERYL MONOSTEARATE HYDROGENATED COCONUT OIL PEG-100 STEARATE SORBITAN MONOOLEATE ACETAMINOPHEN ACETAMINOPHEN"],"version":"6","warnings":["WARNINGS For rectal use only Liver Warning: This product contains acetaminophen. Severe liver damage may occur if • a child 6 to 12 years takes more than 5 doses in 24 hours • an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount • taken with other drugs containing acetaminophen • an adult takes 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 • in children under 6 years • if you are allergic to acetaminophen • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if • you have liver disease • you are taking the blood thinning drug warfarin Stop use and ask a doctor if • fever lasts more than 3 days (72 hours), or recurs • new symptoms occur • pain gets worse or lasts more than 10 days • redness or swelling is present in the painful area These may be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms."]}