{"active_ingredient":["Active ingredient (in each 5 mL) Acetaminophen 160 mg"],"ask_doctor":["Ask a doctor before use if your child has liver disease"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin"],"do_not_use":["Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child has ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning) shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age. remove the child protective cap and squeeze your child’s dose into the dosing cup repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) * under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL 36-47 4-5 years 7.5 mL 48-59 6-8 years 10 mL 60-71 9-10 years 12.5 mL 72-95 11 years 15 mL * or as directed by a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device."],"dosage_and_administration_table":["<table width=\"65%\"><col width=\"31%\"/><col width=\"29%\"/><col width=\"35%\"/><tbody><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Weight (lb)</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Age (yr)</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Dose (mL) <sup>*</sup></content></paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>under 24</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>under 2 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>24-35</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>2-3 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>5 mL</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>36-47</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>4-5 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>7.5 mL</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>48-59</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>6-8 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>10 mL</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>60-71</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>9-10 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>12.5 mL</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>72-95</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>11 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>15 mL</paragraph></td></tr></tbody></table>"],"effective_time":"20250219","id":"2e7eb887-7a73-597f-e063-6394a90a83a7","inactive_ingredient":["Inactive ingredients edetate disodium, non crystallizing sorbitol solution, carbomer homopolymer, maltitol solution, methylparaben, propylparaben, xanthan gum, sucralose, orange flavor, malic acid, sodium hydroxide, purified water"],"indications_and_usage":["Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M013"],"brand_name":["Childrens Acetaminophen"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["Advagen Pharma Limited"],"package_ndc":["72888-459-01"],"product_ndc":["72888-459"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["307668"],"spl_id":["2e7eb887-7a73-597f-e063-6394a90a83a7"],"spl_set_id":["8b9456c9-a56b-4748-adb8-c66d6bf072e8"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Acetaminophen Oral Suspension 16mg/5mL - NDC 72888-459-01 - 118mL Carton Label image Description"],"purpose":["Purpose Pain reliever-fever reducer"],"questions":["Questions or comments? +1-866-488-0312"],"set_id":"8b9456c9-a56b-4748-adb8-c66d6bf072e8","spl_product_data_elements":["Childrens Acetaminophen Acetaminophen EDETATE DISODIUM NONCRYSTALLIZING SORBITOL SOLUTION CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE MALTITOL METHYLPARABEN PROPYLPARABEN XANTHAN GUM MALIC ACID SODIUM HYDROXIDE WATER ACETAMINOPHEN ACETAMINOPHEN"],"spl_unclassified_section":["Distributed by: Advagen Pharma Ltd., East Windsor, NJ 08520, USA www.advagenpharma.com Rev. 00, 09/2024"],"stop_use":["Stop use and ask a doctor if pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition."],"storage_and_handling":["Other information each 5 mL contains: sodium 4 mg store at 20-25 ° C (68-77 ° F) do not use if tamper-evident ring is broken or missing"],"version":"1","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. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child has ever had an allergic reaction to this product or any of its ingredients 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 When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms."],"when_using":["When using this product do not exceed recommended dose (see overdose warning)"]}