{"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 a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin"],"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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product"],"dosage_and_administration":["Directions this product does not contain directions or complete warnings for adult use. do not take 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 repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL (1 unit dose cup) 36-47 4-5 years 7.5 mL (1.5 unit dose cups) 48-59 6-8 years 10 mL (2 unit dose cups) 60-71 9-10 years 12.5 mL (2.5 unit dose cups) 72-95 11 years 15 mL (3 unit dose cups)"],"dosage_and_administration_table":["<table width=\"100%\" styleCode=\"Noautorules\"><col width=\"33%\"/><col width=\"33%\"/><col width=\"33%\"/><tbody><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Weight (lb)</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Age (yr)</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Dose (mL)</content><footnote ID=\"_Ref140575014\">or as directed by a doctor</footnote></paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>under 24</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"><paragraph>under 2 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"><paragraph>ask a doctor</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>24-35</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"><paragraph>2-3 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"><paragraph>5 mL (1 unit dose cup)</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>36-47</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"><paragraph>4-5 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"><paragraph>7.5 mL (1.5 unit dose cups)</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>48-59</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"><paragraph>6-8 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"><paragraph>10 mL (2 unit dose cups)</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>60-71</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"><paragraph>9-10 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"><paragraph>12.5 mL (2.5 unit dose cups)</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph>72-95</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph>11 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph>15 mL (3 unit dose cups)</paragraph></td></tr></tbody></table>"],"effective_time":"20241021","id":"24ffe677-36c2-566c-e063-6394a90a7c00","inactive_ingredient":["Inactive Ingredients: acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum."],"indications_and_usage":["Uses temporarily: reduces fever 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."],"openfda":{"application_number":["M013"],"brand_name":["Childrens Acetaminophen Oral Suspension"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["American Health Packaging"],"package_ndc":["60687-762-40","60687-762-46","60687-762-17"],"product_ndc":["60687-762"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["307668"],"spl_id":["24ffe677-36c2-566c-e063-6394a90a7c00"],"spl_set_id":["8231dd91-e9e6-4350-a485-fa95d65a6d25"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"overdosage":["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 for adults as well as children even if you do not notice any sign or symptoms."],"package_label_principal_display_panel":["Principal Display Panel – Tray – 160 mg/5 mL Case NDC 60687-762-17/Cup NDC 60687-762-40 Children’s Acetaminophen Oral Suspension 160 mg per 5 mL DYE FREE/GRAPE FLAVOR Ibuprofen Free/Alcohol Free/Aspirin Free Pain Reliever-Fever Reducer SHAKE WELL BEFORE USING USUAL DOSAGE: See attached Drug Facts Store at 20° to 25°C (68° to 77°F) For Institutional Use Only. T0966C050423 R04/23 160 mg/5 mL Children’s Acetaminophen Oral Suspension Tray Label","Principal Display Panel – Cup – 160 mg/5 mL NDC 60687- 762 -40 CHILDREN’S ACETAMINOPHEN ORAL SUSPENSION Pain Reliever-Fever Reducer 160 mg per 5 mL DYE FREE/GRAPE FLAVOR Ibuprofen Free/Alcohol Free/Aspirin Free Delivers 5 mL SHAKE WELL BEFORE USING See package Drug Facts inert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0966C50423 160 mg/5 mL Children’s Acetaminophen Oral Suspension Cup"],"purpose":["Purpose Pain reliever/fever reducer"],"questions":["Questions or Comments? Call 1-800-845-8210."],"set_id":"8231dd91-e9e6-4350-a485-fa95d65a6d25","spl_product_data_elements":["Childrens Acetaminophen Oral Suspension Acetaminophen ACESULFAME POTASSIUM BUTYLPARABEN ANHYDROUS CITRIC ACID GLYCERIN HIGH FRUCTOSE CORN SYRUP POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SOLUTION MAGNESIUM ALUMINUM SILICATE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN to off-white appearance grape flavor"],"spl_unclassified_section":["Other information each 5 mL contains: sodium: 2 mg Store at 20° to 25°C (68° to 77°F) grape flavored suspension supplied in the following oral dosage form: 5 mL unit dose cups: 100 cups (10 x 10) NDC 60687-762-17","DO NOT USE IF SEAL IS BROKEN. Distributed by: American Health Packaging Columbus, OH 43217 T0966C050423 R04/23"],"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."],"version":"2","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."],"when_using":["When using this product do not exceed recommended dose (see overdose warning)"]}