{"active_ingredient":["OTC - ACTIVE INGREDIENT Acetaminophen 325 mg"],"dosage_and_administration":["DOSAGE & ADMINISTRATION • 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=\"0\"> <tbody> <tr> <td> <content styleCode=\"bold\">children under 6 years</content> </td> <td> <content styleCode=\"bold\"> do not use   </content> </td> </tr> <tr> <td>children 6-12 years</td> <td> <paragraph> 1 suppository every 4 to 6 hours</paragraph> <paragraph> (maximum of 5 doses in 24 hours)   </paragraph> </td> </tr> <tr> <td> <paragraph>adults and children </paragraph> <paragraph>12 years and older </paragraph> </td> <td> <paragraph> 2 suppositories every 4 to 6 hours</paragraph> <paragraph> (maximum of 6 doses)</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20170308","id":"4a42c883-92a3-533d-e054-00144ff8d46c","inactive_ingredient":["INACTIVE INGREDIENT glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate"],"indications_and_usage":["INDICATIONS & USAGE temporarily • reduces fever • relieves minor aches, pains, and headache"],"keep_out_of_reach_of_children":["OTC - KEEP OUT OF REACH OF CHILDREN • store at room temperature 15˚-30˚C (59˚-86˚F)"],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION DRUG: ACEPHEN GENERIC: Acetaminophen DOSAGE: SUPPOSITORY ADMINSTRATION: RECTAL NDC: 61786-152-07 ACTIVE INGREDIENT(S): Acetaminophen 325mg in 1 INACTIVE INGREDIENT(S): Glyceryl Monostearate Peg-100 Stearate Hydrogenated Coconut Oil Sorbitan Monooleate PACKAGING: 12 in 1 BOX MM1 MM2"],"purpose":["OTC - PURPOSE Pain reliever/fever reducer"],"questions":["OTC - QUESTIONS call 1-800-922-1038"],"set_id":"8136458a-1f35-4ab0-be50-b89bcd10624f","spl_product_data_elements":["ACEPHEN Acetaminophen GLYCERYL MONOSTEARATE PEG-100 STEARATE HYDROGENATED COCONUT OIL SORBITAN MONOOLEATE ACETAMINOPHEN ACETAMINOPHEN"],"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."]}