{"active_ingredient":["Active ingredient (in each rectal suppository) Acetaminophen 120 mg"],"ask_doctor":["Ask a doctor before use if • your child has liver disease • your child is taking the blood thinning drug warfarin"],"do_not_use":["Do not use • 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."],"dosage_and_administration":["Directions • this product does not contain directions or warnings for adult use • do not use more than directed • remove wrapper • carefully insert suppository well up into the rectum Dosing Chart Age Dose under 3 years Do not use unless directed by a doctor 3 to 6 years Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"30%\"/><col width=\"70%\"/><tbody><tr><td align=\"center\" colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Dosing Chart</paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>Age</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Dose</paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>under 3 years</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Do not use unless directed by a doctor</paragraph></td></tr><tr><td styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph>3 to 6 years</paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)</paragraph></td></tr></tbody></table>"],"effective_time":"20220901","id":"a4458cf8-9a74-4beb-858c-611588e6b6b0","inactive_ingredient":["Inactive ingredient hydrogenated vegetable oil"],"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. (1-800-222-1222) Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["ANDA070607"],"brand_name":["acetaminophen for children"],"generic_name":["ACETAMINOPHEN"],"manufacturer_name":["Proficient Rx LP"],"original_packager_product_ndc":["45802-732"],"package_ndc":["63187-373-12"],"product_ndc":["63187-373"],"product_type":["HUMAN OTC DRUG"],"route":["RECTAL"],"rxcui":["198434"],"spl_id":["a4458cf8-9a74-4beb-858c-611588e6b6b0"],"spl_set_id":["43fd900c-50c8-49c4-9f07-4fef924d533c"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"package_label_principal_display_panel":["Principal Display Panel Compare to FeverAll® active ingredient For Children Acetaminophen Suppositories USP, 120 mg Pain Reliever/Fever Reducer Ages 3-6 years See New Warning 12 RECTAL SUPPOSITORIES, 120 mg EACH 63187-373-12"],"purpose":["Purposes Pain reliever/fever reducer"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"43fd900c-50c8-49c4-9f07-4fef924d533c","spl_product_data_elements":["acetaminophen for children Acetaminophen ACETAMINOPHEN ACETAMINOPHEN COTTONSEED OIL"],"stop_use":["Stop use and ask a doctor if • fever lasts more than 3 days (72 hours), or recurs. • pain lasts more than 5 days or gets worse. • new symptoms occur. • redness or swelling is present in the painful area. These may be signs of a serious condition."],"storage_and_handling":["Other information • store at 20-25 ° C (68-77 ° F) or in a cool place • tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged. Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320"],"version":"5","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes • more than 5 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen 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. For rectal use only Do not use • 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 • your child has liver disease • 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. • pain lasts more than 5 days or gets worse. • new symptoms occur. • redness or swelling is present in the painful area. These may be signs of a serious condition. Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms."]}