{"active_ingredient":["Active ingredient (in each 5 mL) Acetaminophen 160 mg"],"ask_doctor":["Ask a doctor before use if your child has liver disease","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."],"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 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)"],"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. If possible, use weight to dose; otherwise, use age. • push air out of syringe. Insert syringe tip into bottle opening. • flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle. • pull yellow part of syringe until it reaches and stays at the correct dose • dispense liquid slowly into child’s mouth, toward inner cheek • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • replace cap tightly to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL *or as directed by a doctor Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device."],"dosage_and_administration_table":["<table width=\"100%\"> <col width=\"13%\"/> <col width=\"15%\"/> <col width=\"13%\"/> <tbody> <tr> <td align=\"center\" colspan=\"3\" styleCode=\"Botrule \" valign=\"top\"> <paragraph>Dosing Chart</paragraph> </td> </tr> <tr> <td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>Weight (lb)</paragraph> </td> <td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>Age (yr)</paragraph> </td> <td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>Dose (mL)*</paragraph> </td> </tr> <tr> <td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>under 24</paragraph> </td> <td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>under 2 years</paragraph> </td> <td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>ask a doctor</paragraph> </td> </tr> <tr> <td align=\"center\" styleCode=\"Botrule Lrule \" valign=\"top\"> <paragraph>24-35</paragraph> </td> <td align=\"center\" styleCode=\"Botrule Lrule \" valign=\"top\"> <paragraph>2-3 years</paragraph> </td> <td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"> <paragraph>5 mL</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20181210","id":"39794e2c-7c5a-4279-ad1e-976e71e10c2f","inactive_ingredient":["Inactive ingredients anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate"],"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":{},"package_label_principal_display_panel":["Package/Label Principal Display Panel SEE NEW WARNINGS Compare to Infants’ Tylenol® Oral Suspension active ingredient For Ages 2-3 Years Infants’ Pain & Fever Acetaminophen 160 mg per 5 mL Oral Suspension Fever Reducer – Pain Reliever Pediatrician Preferred Dosing System Alcohol Free Aspirin Free Ibuprofen Free Use only with enclosed syringe. See side panel for more information. Cherry Flavor Non-Staining – Dye-Free 2 FL OZ (59 mL) Leaders Infants' Pain & Fever image 1 Leader Infants' Pain & Fever image 2"],"purpose":["Purpose Pain reliever/fever reducer"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"0a0889de-61ba-4e23-8051-6e842826b83c","spl_product_data_elements":["leader pain and fever acetaminophen ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID CALCIUM SULFATE CARRAGEENAN GLYCERIN CELLULOSE, MICROCRYSTALLINE CARBOXYMETHYLCELLULOSE SODIUM PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM BENZOATE SORBITOL SUCRALOSE SODIUM PHOSPHATE, TRIBASIC"],"spl_unclassified_section":["Other information • store at 20-25ºC (68-77ºF) • do not use if printed neckband is broken or missing"],"version":"4","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)"]}