{"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 cellpadding=\"0.4pt\" cellspacing=\"0pt\" width=\"100%\"> <col width=\"49%\"/> <col width=\"49%\"/> <tbody> <tr> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph> <content styleCode=\"bold\">children under 6 years</content> </paragraph> </td> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph> <content styleCode=\"bold\">do not use</content> </paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>children 6-12 years</paragraph> </td> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"> <paragraph>adults and children 12 years and older</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"> <paragraph>2 suppositories every 4 to 6 hours (maximum of 6 doses)</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20190502","id":"02c9c10d-12f6-4653-91fd-da545966a66e","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 68788-8934 ACEPHEN TM ACETAMINOPHEN SUPPOSITORIES USP 325 mg Pain Reliever • Fever Reducer 12 Rectal Suppositories Acetaminophen Suppositories 325mg"],"purpose":["PURPOSE Pain reliever/fever reducer"],"questions":["QUESTIONS ? call 1-800-922-1038"],"set_id":"ecc8eee3-5123-45a2-a708-db4e52d78995","spl_product_data_elements":["ACEPHEN Acetaminophen Acetaminophen Acetaminophen Glyceryl Monostearate Hydrogenated Coconut Oil Peg-100 Stearate Sorbitan Monooleate"],"version":"2","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."]}