{"active_ingredient":["ACTIVE INGREDIENT (in each rectal suppository) Acetaminophen 120 mg"],"dosage_and_administration":["DOSAGE & ADMINISTRATION Directions This product does not contain directions or complete warnings for adult use. • do not use more than directed • remove foil wrapper • insert suppository well up into rectum • children 3-6 years: • 1 suppository every 4 to 6 hours while symptoms persist • do not exceed 5 suppositories in any 24-hour period • children under 3 years: ask a doctor"],"effective_time":"20120606","id":"301ec476-d899-4616-be96-910bcb384d08","inactive_ingredient":["INACTIVE INGREDIENT butylated hydroxyanisole, butylated hydroxytoluene, glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, polysorbate 80"],"indications_and_usage":["USES temporarily • reduces fever • relieves minor aches, pains, and headache"],"keep_out_of_reach_of_children":["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 children even if you do not notice any signs or symptoms."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SEE NEW WARNINGS INFORMATION READ AND KEEP CARTON FOR NEW LIVER WARNING NDC 54868-5624-0 12 rectal suppositories Acetaminophen Suppositories USP 120 mg ASPIRIN FREE Pain Reliever • Fever Reducer 50 Rectal Suppositories"],"purpose":["PURPOSE pain reliever/fever reducer"],"questions":["QUESTIONS call 1-800-922-1038 Monday-Friday 9am-4pm EST"],"set_id":"c383bf5b-7043-4f0c-bddb-590aea545859","spl_product_data_elements":["Acetaminophen Acetaminophen Acetaminophen Acetaminophen Butylated Hydroxyanisole Butylated Hydroxytoluene Glyceryl Monostearate Hydrogenated Coconut Oil Peg-100 Stearate Polysorbate 80 Packaging Carton"],"spl_unclassified_section":["Other Information • for your safety, suppositories are packaged in tamper-evident sealed foil. Do not use if foil is torn or open. • store at 8˚-25˚C (46˚-77˚F)"],"version":"1","warnings":["WARNINGS For rectal use only Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child inserts: • more than 5 suppositories in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen Do not use • if your child is 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 your child has liver disease Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin Stop use and ask a doctor if • fever lasts more than 3 days (72 hours), or recurs • you need to use this product for pain for more than 5 days continuously Severe or recurrent pain, or high or continued fever may indicate a serious illness."]}