{"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 a suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)"],"dosage_and_administration_table":["<table width=\"100%\"> <col width=\"26%\"/> <col width=\"60%\"/> <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 a suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20161027","id":"c1cea2eb-fea9-4d11-8afa-3151d30bbc1c","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":{},"package_label_principal_display_panel":["Principal Display Panel AGES 3 – 6 YEARS For Children Fever Reducer ACETAMINOPHEN SUPPOSITORIES 120 mg Pain reliever / Fever reducer SEE NEW WARNING COMPARE TO FEVERALL® active ingredient 12 RECTAL SUPPOSITORIES 120 mg EACH TopCare Fever Reducer"],"purpose":["Purposes Pain reliever/fever reducer"],"questions":["Questions or comments? 1-888-423-0139"],"set_id":"72a33640-ca7f-460d-9357-772d5bf56bac","spl_product_data_elements":["topcare fever reducer 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."],"version":"3","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."]}